NCT02608268

Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

Terminated Phase 1, PHASE2 Results posted Last updated 6 December 2023

What this trial tests

Phase 1, PHASE2 trial testing MBG453 in Advanced Malignancies in 252 participants. Terminated before completion.

Timeline

23 November 2015

Primary endpoint
30 August 2022

30 August 2022

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	252
Start date	23 November 2015
Primary completion	30 August 2022
Estimated completion	30 August 2022
Sites	14 locations across Italy, Japan, Netherlands, Taiwan, South Korea, Canada, Switzerland, Singapore

Drugs / interventions tested

• MBG453 — full drug profile →
• PDR001 — full drug profile →
• Decitabine (decitabine) — full drug profile →

Conditions studied

• Advanced Malignancies — all drugs for Advanced Malignancies →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Advanced Malignancies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase I-Ib and Dose Ranging Part: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Primary · From first dose of study medication up to 30 days after last dose, with a maximum duration of 2 years for sabatolimab and 5 years for sabatolimab in combination with spartalizumab

Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last

AEs

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	13
Phase I Dose Escalation: MBG453 240mg Q2W ROW	9
Phase I Dose Escalation: MBG453 800mg Q2W ROW	14
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	5
Phase I Dose Escalation: MBG453 80mg Q2W Japan	2
Phase I Dose Escalation: MBG453 240mg Q2W Japan	3
Phase I Dose Escalation: MBG453 800mg Q2W Japan	6
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	2
Phase I Dose Escalation: MBG453 240mg Q4W ROW	7
Phase I Dose Escalation: MBG453 800mg Q4W ROW	9
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	6
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	5

Treatment-related AEs

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	9
Phase I Dose Escalation: MBG453 240mg Q2W ROW	5
Phase I Dose Escalation: MBG453 800mg Q2W ROW	6
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	1
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	1
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	4
Phase I Dose Escalation: MBG453 800mg Q4W ROW	6
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	2
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	1

AEs with grade ≥ 3

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	5
Phase I Dose Escalation: MBG453 240mg Q2W ROW	3
Phase I Dose Escalation: MBG453 800mg Q2W ROW	6
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	2
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	1
Phase I Dose Escalation: MBG453 800mg Q2W Japan	2
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	3
Phase I Dose Escalation: MBG453 800mg Q4W ROW	7
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	4
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	3

Treatment-related AEs with grade ≥ 3

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

SAEs

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	4
Phase I Dose Escalation: MBG453 240mg Q2W ROW	1
Phase I Dose Escalation: MBG453 800mg Q2W ROW	6
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	2
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	1
Phase I Dose Escalation: MBG453 800mg Q4W ROW	5
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	4
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

Fatal SAEs

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	2
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	1
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

AEs leading to discontinuation

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	1
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	1
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

AEs leading to dose adjustment/interruption

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	3
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	3
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	1
Phase I Dose Escalation: MBG453 800mg Q2W Japan	1
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	1
Phase I Dose Escalation: MBG453 240mg Q4W ROW	1
Phase I Dose Escalation: MBG453 800mg Q4W ROW	2
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	1

Phase I-Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) Primary · 28 days (sabatolimab single agent) and 56 days (sabatolimab+spartalizumab)

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with sabatolimab as single agent or in the first two cycles of treatment when sabatolimab is given in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. T

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

Phase I-Ib and Dose Ranging Part: Number of Participants With Dose Reductions and Dose Interruptions of Sabatolimab Primary · From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab.

At least one dose reduction

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	2
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	1
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

At least one dose interruption

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	2
Phase I Dose Escalation: MBG453 240mg Q2W ROW	1
Phase I Dose Escalation: MBG453 800mg Q2W ROW	3
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	2
Phase I Dose Escalation: MBG453 800mg Q2W Japan	1
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	1
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0

Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab Primary · From first dose of study medication up to last dose, with a maximum duration of 4.9 years

Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab.

At least one dose reduction

Group	Value	95% CI
Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W	0
Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W	1
Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W	0
Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W	0
Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W	0
Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W	0
Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W	0
Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W	0
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W	0
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W	0
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W	0
Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W	0

At least one dose interruption

Group	Value	95% CI
Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W	2
Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W	2
Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W	1
Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W	1
Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W	2
Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W	1
Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W	1
Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W	0
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W	0
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W	0
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W	2
Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W	1

Phase I-Ib and Dose Ranging Part: Dose Intensity of Sabatolimab Primary · From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

Dose intensity of sabatolimab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of sabatolimab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	78.35	± 4.678
Phase I Dose Escalation: MBG453 240mg Q2W ROW	235.60	± 17.140
Phase I Dose Escalation: MBG453 800mg Q2W ROW	728.06	± 164.525
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	1203.03	± 15.891
Phase I Dose Escalation: MBG453 80mg Q2W Japan	80.00	± 0.000
Phase I Dose Escalation: MBG453 240mg Q2W Japan	217.50	± 28.723
Phase I Dose Escalation: MBG453 800mg Q2W Japan	758.03	± 57.03
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	1208.70	± 12.298
Phase I Dose Escalation: MBG453 240mg Q4W ROW	240.19	± 1.954
Phase I Dose Escalation: MBG453 800mg Q4W ROW	752.29	± 123.021
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	1193.10	± 16.893
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	1196.49	± 8.595

Phase Ib: Dose Intensity of Spartalizumab Primary · From first dose of study medication up to last dose, with a maximum duration of 4.9 years

Dose intensity of spartalizumab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of spartalizumab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.

Group	Value	95% CI
Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W	77.36	± 4.171
Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W	77.83	± 3.957
Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W	78.73	± 5.017
Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W	230.24	± 19.982
Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W	74.39	± 7.953
Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W	229.12	± 26.871
Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W	76.39	± 5.315
Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W	400.53	± 0.920
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W	79.79	± 1.409
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W	236.00	± 7.800
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W	383.22	± 36.754
Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W	377.89	± 51.948

Phase II: Overall Response Rate (ORR) Per RECIST v1.1 Primary · From start of treatment until end of treatment, assessed up to 2.9 years

Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Group	Value	95% CI
Phase II: MBG453 + PDR001 NSCLC	0	0.0 – 16.2
Phase II: MBG453 + PDR001 Melanoma	0	0.0 – 17.1

Best Overall Response (BOR) Per RECIST v1.1 Secondary · From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the sma

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0
Phase I Dose Escalation: MBG453 800mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0
Phase I Dose Escalation: MBG453 80mg Q2W ROW	4
Phase I Dose Escalation: MBG453 240mg Q2W ROW	3
Phase I Dose Escalation: MBG453 800mg Q2W ROW	7
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q2W Japan	1
Phase I Dose Escalation: MBG453 800mg Q2W Japan	2
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0
Phase I Dose Escalation: MBG453 240mg Q4W ROW	3
Phase I Dose Escalation: MBG453 800mg Q4W ROW	1
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	3
Phase I Dose Escalation: MBG453 80mg Q2W ROW	7
Phase I Dose Escalation: MBG453 240mg Q2W ROW	6
Phase I Dose Escalation: MBG453 800mg Q2W ROW	8
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	5
Phase I Dose Escalation: MBG453 80mg Q2W Japan	2
Phase I Dose Escalation: MBG453 240mg Q2W Japan	3
Phase I Dose Escalation: MBG453 800mg Q2W Japan	4
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	2
Phase I Dose Escalation: MBG453 240mg Q4W ROW	3
Phase I Dose Escalation: MBG453 800mg Q4W ROW	4
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	4
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	3

Progression-Free Survival (PFS) Per RECIST v1.1 Secondary · From start of treatment until first documented progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates.

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	1.8	1.7 – 3.3
Phase I Dose Escalation: MBG453 240mg Q2W ROW	1.8	1.6 – 2.8
Phase I Dose Escalation: MBG453 800mg Q2W ROW	1.8	1.7 – 5.3
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	1.7	1.3 – NA
Phase I Dose Escalation: MBG453 80mg Q2W Japan	1.5	1.4 – NA
Phase I Dose Escalation: MBG453 240mg Q2W Japan	1.9	1.0 – NA
Phase I Dose Escalation: MBG453 800mg Q2W Japan	2.0	1.0 – 3.3
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	1.6	1.4 – NA
Phase I Dose Escalation: MBG453 240mg Q4W ROW	1.7	1.0 – NA
Phase I Dose Escalation: MBG453 800mg Q4W ROW	1.7	0.7 – 1.8
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	1.8	1.6 – NA
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	2.0	1.1 – 3.5

Duration of Response (DOR) Per RECIST v1.1 Secondary · From first documented response to first documented disease progression or death due to underlying cancer, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST v1.1. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, duration was censored at the date of last adequate tumor assessment. According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients a

Group	Value	95% CI
Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W	NA	NA – NA
Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W	NA	NA – NA
Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W	NA	NA – NA
Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W	NA	NA – NA

Overall Response Rate (ORR) Per irRC Secondary · From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of di

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	0	0.0 – 19.3
Phase I Dose Escalation: MBG453 240mg Q2W ROW	0	0.0 – 28.3
Phase I Dose Escalation: MBG453 800mg Q2W ROW	0	0.0 – 17.1
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	0	0.0 – 45.1
Phase I Dose Escalation: MBG453 80mg Q2W Japan	0	0.0 – 77.6
Phase I Dose Escalation: MBG453 240mg Q2W Japan	0	0.0 – 52.7
Phase I Dose Escalation: MBG453 800mg Q2W Japan	0	0.0 – 39.3
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	0	0.0 – 77.6
Phase I Dose Escalation: MBG453 240mg Q4W ROW	0	0.0 – 31.2
Phase I Dose Escalation: MBG453 800mg Q4W ROW	0	0.0 – 28.3
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	0	0.0 – 39.3
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	0	0.0 – 39.3

Progression-Free Survival (PFS) Per irRC Secondary · From start of treatment until first documented and confirmed progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab

PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor evaluation. Tumor response was based on local investigator assessment per irRC. PFS was analyzed using Kaplan-Meier estimates.

Group	Value	95% CI
Phase I Dose Escalation: MBG453 80mg Q2W ROW	1.8	1.7 – 3.3
Phase I Dose Escalation: MBG453 240mg Q2W ROW	1.8	1.6 – 3.0
Phase I Dose Escalation: MBG453 800mg Q2W ROW	1.8	1.7 – 5.3
Phase I Dose Escalation: MBG453 1200mg Q2W ROW	1.7	1.3 – NA
Phase I Dose Escalation: MBG453 80mg Q2W Japan	1.5	1.4 – NA
Phase I Dose Escalation: MBG453 240mg Q2W Japan	1.9	1.0 – NA
Phase I Dose Escalation: MBG453 800mg Q2W Japan	2.0	1.0 – 3.3
Phase I Dose Escalation: MBG453 1200mg Q2W Japan	1.6	1.4 – NA
Phase I Dose Escalation: MBG453 240mg Q4W ROW	1.7	1.0 – NA
Phase I Dose Escalation: MBG453 800mg Q4W ROW	1.8	0.7 – 2.5
Phase I Dose Escalation: MBG453 1200mg Q4W ROW	2.3	1.8 – NA
Phase I Dose Escalation: MBG453 1200mg Q4W Japan	2.0	1.1 – 3.5

Adverse events — posted to ClinicalTrials.gov

Time frame: On-treatment and post-treatment safety follow-up: from first dose of study treatment to 30 days after last dose (sabatolimab) and to 150 days after last dose (sabatolimab+spartalizumab), up to 2 years for single agent and 5.3 years (phase Ib)/3.3 years (phase II) for combination. Deaths in survival period: from 31 days (single agent) and 151 days (combination) after last dose until end of study, up to 2 years for single agent and 5.3 years (phase Ib)/3.3 years (phase II) for combination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase I Dose Escalation: MBG453 80mg Q2W ROW

Serious: 6/14 (43%)

Deaths: 9/14

Phase I Dose Escalation: MBG453 240mg Q2W ROW

Serious: 1/9 (11%)

Deaths: 4/9

Phase I Dose Escalation: MBG453 800mg Q2W ROW

Serious: 9/16 (56%)

Deaths: 6/16

Phase I Dose Escalation: MBG453 1200mg Q2W ROW

Serious: 2/5 (40%)

Deaths: 5/5

Phase I Dose Escalation: MBG453 80mg Q2W Japan

Serious: 0/2 (0%)

Deaths: 1/2

Phase I Dose Escalation: MBG453 240mg Q2W Japan

Serious: 0/4 (0%)

Deaths: 4/4

Phase I Dose Escalation: MBG453 800mg Q2W Japan

Serious: 0/6 (0%)

Deaths: 5/6

Phase I Dose Escalation: MBG453 1200mg Q2W Japan

Serious: 0/2 (0%)

Deaths: 1/2

Phase I Dose Escalation: MBG453 240mg Q4W ROW

Serious: 3/8 (38%)

Deaths: 3/8

Phase I Dose Escalation: MBG453 800mg Q4W ROW

Serious: 6/9 (67%)

Deaths: 4/9

Phase I Dose Escalation: MBG453 1200mg Q4W ROW

Serious: 4/6 (67%)

Deaths: 4/6

Phase I Dose Escalation: MBG453 1200mg Q4W Japan

Serious: 0/6 (0%)

Deaths: 3/6

Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W

Serious: 2/6 (33%)

Deaths: 1/6

Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W

Serious: 7/13 (54%)

Deaths: 5/13

Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W

Serious: 2/6 (33%)

Deaths: 2/6

Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W

Serious: 5/5 (100%)

Deaths: 5/5

Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W

Serious: 4/5 (80%)

Deaths: 2/5

Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W

Serious: 0/6 (0%)

Deaths: 3/6

Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W

Serious: 4/6 (67%)

Deaths: 0/6

Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W

Serious: 1/3 (33%)

Deaths: 3/3

Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W

Serious: 2/12 (17%)

Deaths: 5/12

Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W

Serious: 3/5 (60%)

Deaths: 2/5

Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W

Serious: 2/7 (29%)

Deaths: 1/7

Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W

Serious: 4/6 (67%)

Deaths: 2/6

Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W

Serious: 5/6 (83%)

Deaths: 4/6

Dose Ranging Part: MBG453 80mg Q4W

Serious: 10/14 (71%)

Deaths: 8/14

Dose Ranging Part: MBG453 240mg Q4W

Serious: 8/17 (47%)

Deaths: 9/17

Dose Ranging Part: MBG453 1200mg Q4W

Serious: 9/15 (60%)

Deaths: 6/15

Phase II: MBG453 + PDR001 NSCLC

Serious: 9/17 (53%)

Deaths: 9/17

Phase II: MBG453 + PDR001 Melanoma

Serious: 5/16 (31%)

Deaths: 6/16

Phase I Dose Escalation: MBG453 80mg Q2W ROW - Survival Period

Serious: 0

Deaths: 3/5

Phase I Dose Escalation: MBG453 240mg Q2W ROW - Survival Period

Serious: 0

Deaths: 4/5

Phase I Dose Escalation: MBG453 800mg Q2W ROW - Survival Period

Serious: 0

Deaths: 7/10

Phase I Dose Escalation: MBG453 1200mg Q2W ROW - Survival Period

Serious: 0

Deaths: 0

Phase I Dose Escalation: MBG453 80mg Q2W Japan - Survival Period

Serious: 0

Deaths: 1/1

Phase I Dose Escalation: MBG453 240mg Q2W Japan - Survival Period

Serious: 0

Deaths: 0

Phase I Dose Escalation: MBG453 800mg Q2W Japan - Survival Period

Serious: 0

Deaths: 1/1

Phase I Dose Escalation: MBG453 1200mg Q2W Japan - Survival Period

Serious: 0

Deaths: 1/1

Phase I Dose Escalation: MBG453 240mg Q4W ROW - Survival Period

Serious: 0

Deaths: 3/5

Phase I Dose Escalation: MBG453 800mg Q4W ROW - Survival Period

Serious: 0

Deaths: 3/5

Phase I Dose Escalation: MBG453 1200mg Q4W ROW - Survival Period

Serious: 0

Deaths: 1/2

Phase I Dose Escalation: MBG453 1200mg Q4W Japan - Survival Period

Serious: 0

Deaths: 3/3

Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W - Survival Period

Serious: 0

Deaths: 2/5

Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W - Survival Period

Serious: 0

Deaths: 4/8

Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W - Survival Period

Serious: 0

Deaths: 3/4

Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W - Survival Period

Serious: 0

Deaths: 0

Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W - Survival Period

Serious: 0

Deaths: 2/3

Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W - Survival Period

Serious: 0

Deaths: 2/3

Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W - Survival Period

Serious: 0

Deaths: 2/6

Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W - Survival Period

Serious: 0

Deaths: 0

Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W - Survival Period

Serious: 0

Deaths: 6/7

Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W - Survival Period

Serious: 0

Deaths: 2/3

Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W - Survival Period

Serious: 0

Deaths: 3/6

Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W - Survival Period

Serious: 0

Deaths: 2/4

Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W - Survival Period

Serious: 0

Deaths: 1/2

Dose Ranging Part: MBG453 80mg Q4W - Survival Period

Serious: 0

Deaths: 4/6

Dose Ranging Part: MBG453 240mg Q4W - Survival Period

Serious: 0

Deaths: 3/8

Dose Ranging Part: MBG453 1200mg Q4W - Survival Period

Serious: 0

Deaths: 7/9

Phase II: MBG453 + PDR001 NSCLC - Survival Period

Serious: 0

Deaths: 8/8

Phase II: MBG453 + PDR001 Melanoma - Survival Period

Serious: 0

Deaths: 7/10

Serious adverse events (121 terms)

Reaction	System	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Phase II: MBG453 + PDR001 …	Phase II: MBG453 + PDR001 …	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Phase II: MBG453 + PDR001 …	Phase II: MBG453 + PDR001 …
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood loss anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Disseminated intravascular coagulation	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Left ventricular dysfunction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Duodenal stenosis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (371 terms — click to expand)

Reaction	System	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Phase II: MBG453 + PDR001 …	Phase II: MBG453 + PDR001 …	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase I Dose Escalation: M…	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Phase Ib Dose Escalation: …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Dose Ranging Part: MBG453 …	Phase II: MBG453 + PDR001 …	Phase II: MBG453 + PDR001 …
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Liver disorder	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gait disturbance	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Vomiting, Ascites, Intestinal obstruction, Nausea, Subileus, Pyrexia, Back pain.

Data from ClinicalTrials.gov NCT02608268 adverse events section.

Sponsor's own description

The purpose of this first-in-human study of MBG453 was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 or decitabine in adult patients with advanced solid tumors

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy in colorectal cancer: rationale, challenges and potential.
   Ganesh K, Stadler ZK, Cercek A, Mendelsohn RB, et al · · 2019 · cited 1407× · PMID 30886395 · DOI 10.1038/s41575-019-0126-x
2. PD-1 and PD-L1 Checkpoint Signaling Inhibition for Cancer Immunotherapy: Mechanism, Combinations, and Clinical Outcome.
   Alsaab HO, Sau S, Alzhrani R, Tatiparti K, et al · · 2017 · cited 1206× · PMID 28878676 · DOI 10.3389/fphar.2017.00561
3. Hallmarks of response, resistance, and toxicity to immune checkpoint blockade.
   Morad G, Helmink BA, Sharma P, Wargo JA. · · 2021 · cited 1197× · PMID 34624224 · DOI 10.1016/j.cell.2021.09.020
4. Comprehensive review of targeted therapy for colorectal cancer.
   Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
5. Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
   Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
6. Novel immune checkpoint targets: moving beyond PD-1 and CTLA-4.
   Qin S, Xu L, Yi M, Yu S, et al · · 2019 · cited 909× · PMID 31690319 · DOI 10.1186/s12943-019-1091-2
7. TIM3 comes of age as an inhibitory receptor.
   Wolf Y, Anderson AC, Kuchroo VK. · · 2020 · cited 755× · PMID 31676858 · DOI 10.1038/s41577-019-0224-6
8. Next generation of immune checkpoint therapy in cancer: new developments and challenges.
   Marin-Acevedo JA, Dholaria B, Soyano AE, Knutson KL, et al · · 2018 · cited 582× · PMID 29544515 · DOI 10.1186/s13045-018-0582-8