NCT04047862

Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors

Completed Phase 1 Results posted Last updated 22 August 2025

What this trial tests

Phase 1 trial testing Ociperlimab in Locally Advanced and Metastatic Solid Tumors in 446 participants. Completed in 7 August 2024.

Timeline

15 August 2019

Primary endpoint
7 August 2024

7 August 2024

Quick facts

Lead sponsor	BeiGene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	446
Start date	15 August 2019
Primary completion	7 August 2024
Estimated completion	7 August 2024
Sites	65 locations across New Zealand, Taiwan, South Korea, Australia, China, United States

Drugs / interventions tested

• Ociperlimab
• Tislelizumab (TISLELIZUMAB) — full drug profile →
• Pemetrexed — full drug profile →
• Paclitaxel
• Nab paclitaxel
• Carboplatin
• Cisplatin (cisplatin) — full drug profile →
• Etoposide
• 5fluorouracil
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Capecitabine (capecitabine) — full drug profile →

Conditions studied

• Locally Advanced and Metastatic Solid Tumors — all drugs for Locally Advanced and Metastatic Solid Tumors →

Sponsor

BeiGene — full company profile →

Who can join

18 and older, any sex, with Locally Advanced and Metastatic Solid Tumors. 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 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Primary · Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])

An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of

Participants with any TEAE

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	1
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	3
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	6
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	15
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	6
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	9
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	11

Participants with >= Grade 3 TEAE

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	1
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	2
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	4
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	11
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	2
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	4
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	5

Serious TEAE

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	1
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	2
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	3
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	9
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	1
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	3
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	5

Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) Primary · Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts)

The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, \>= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or \<=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting \> 7 days; \>=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting \> 7 days; \>=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tisl

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	0
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	0
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	0
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	0
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	0
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	0
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	0

Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab Primary · Up to 28 days (Dose escalation cohort)

MAD was defined as the highest dose of ociperlimab administered.

Group	Value	95% CI
Phase 1: Dose Escalation: All Participants	1800

Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab Primary · up to 28 days (Dose escalation cohorts)

RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts.

Group	Value	95% CI
Phase 1: Dose Escalation: All Participants	900

Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 Primary · Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)

ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Group	Value	95% CI
Phase 1b: Dose Expansion: Cohort 1	55	38.5 – 70.7
Phase 1b: Dose Expansion: Cohort 2	54.8	38.7 – 70.2
Phase 1b: Dose Expansion: Cohort 3	40.0	25.7 – 55.7
Phase 1b: Dose Expansion: Cohort 4	65.9	49.4 – 79.9
Phase 1b: Dose Expansion: Cohort 5	7.7	0.9 – 25.1
Phase 1b: Dose Expansion: Cohort 6	68.4	43.4 – 87.4
Phase 1b: Dose Expansion: Cohort 7	33.3	4.3 – 77.7
Phase 1b: Dose Expansion: Cohort 8	33.3	19.1 – 50.2
Phase 1b: Dose Expansion: Cohort 9	50.8	37.5 – 64.1
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)	34.8	16.4 – 57.3
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)	26.3	9.1 – 51.2
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)	34.8	16.4 – 57.3

Phase 1: ORR as Per RECIST v.1.1 Secondary · Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts)

ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	0.0	0.0 – 97.5
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	0.0	0.0 – 70.8
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	16.7	0.4 – 64.1
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	6.3	0.2 – 30.2
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	20	0.5 – 71.6
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	0.0	0.0 – 33.6
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	10	0.3 – 44.5

Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 Secondary · From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])

DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression (PD) or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	2.8	NA – NA
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	3.6	NA – NA
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	8.4	NA – NA
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	7	NA – NA

Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 Secondary · From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])

DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	0	0 – 97.5
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	33.3	0.8 – 90.6
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	50	11.8 – 88.2
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	50	24.7 – 75.3
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	40	5.3 – 85.3
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	33.3	7.5 – 70.1
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	50	18.7 – 81.3

Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab Secondary · C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days)

Serum concentrations of ociperlimab were measured. Post-dose refers to the data collected for 30 minutes post-infusion. "C" in the timeframe below refers to "Cycle" and D refers to "Day" and "h" refers to "hours".

Cycle 1 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	NA	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	NA	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	NA	± NA
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	NA	± NA
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	NA	± NA

Cycle 1 Day 1 post-dose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	14.70	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	44.59	± 32
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	130.22	± 19
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	259.66	± 21
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	525.97	± 29

Cycle 1 Day 1- 24 h

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	10.30	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	31.67	± 16
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	98.28	± 16
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	198.72	± 14
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	374.44	± 29

Cycle 1 Day 1- 72 h

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	6.49	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	18.43	± 20
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	64.36	± 29
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	136.15	± 12
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	256.28	± 35

Cycle 1 Day 1- 168 h

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	2.58	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	11.49	± 13
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	41.16	± 43
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	90.08	± 23
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	150.95	± 31

Cycle 1 Day 1- 336 h

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	1.34	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	7.03	± 28
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	29.30	± 46
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	64.72	± 21
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	101.42	± 40

Cycle 2 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	0.33	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	2.23	± 42
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	8.71	± 109
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	24.96	± 71
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	23.85	± 87

Cycle 2 Day 1- Post-dose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	13.90	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	48.11	± 39
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	145.89	± 30
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	277.69	± 20
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	460.48	± 45

Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab Secondary · Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days)

Serum Concentrations of Tislelizumab was determined. Post-dose refers to the data collected for 30 minutes post-infusion.

Cycle 1 Day 8 Predose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	0.45	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	16.50	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	14.46	± 350
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	18.60	± 528
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	NA	± NA

Cycle 1 Day 8 Post-dose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	54.60	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	62.89	± 38
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	82.34	± 48
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	67.93	± 46
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	60.28	± 27

Cycle 2 Day 1 Predose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg	11.50	± NA
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	14.17	± 69
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	20.05	± 93
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	18.61	± 82
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	10.37	± 72

Cycle 5 Day 1 Predose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	17.50	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	30.79	± 32
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	21.91	± 109
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	33.64	± 28

Cycle 5 Day 1 Postdose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	63.40	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	102.03	± 5
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	76.71	± 29
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	98.97	± 21

Cycle 6 Day 1 Predose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	27.60	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	24.08	± 38
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	29.22	± 74
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	40.73	± 18

Cycle 9 Day 1 Predose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	29.10	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	36.28	± 34
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	30.73	± 34
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	37.67	± 6

Cycle 13 Day 1 Predose

Group	Value	95% CI
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg	27.60	± NA
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg	36.70	± NA
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg	33.60	± NA
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg	25.02	± 39

Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab Secondary · Pre-dose, post-dose, 24 h,72 h,168 h,336 h post-dose C1D1, Pre-dose, post-dose on C2D1, Pre-dose, post-dose,168 h, 336 h post-dose on C5D1, Pre-dose, post-dose on C6D1, pre-dose C9D1 and C13D1 (each cycle = 21 days)

Serum concentration of ociperlimab was determined. Post-dose refers to the data collected for 30 minutes post-infusion. "C" in the timeframe below refers to "Cycle" and D refers to "Day" and "h" refers to "hours".

Cycle 1 Day 1- Predose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	NA	± NA
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	NA	± NA

Cycle 1 Day 1- Post-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	313.57	± 21
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	267.78	± 27

Cycle 1 Day 1- 24 h

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	230.81	± 29
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	201.98	± 20

Cycle 1 Day 1- 72 h

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	138.16	± 43
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	141.37	± 15

Cycle 1 Day 1- 168 h

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	102.68	± 27
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	99.84	± 20

Cycle 1 Day 1- 336 h

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	67.27	± 52
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	59.10	± 28

Cycle 2 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	42.52	± 58
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	30.53	± 58

Cycle 2 Day 1- Post-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)	336.36	± 24
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	316.63	± 13

Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab Secondary · Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), Cycle 6 Day 1 (pre-dose), Cycle 9 Day 1 (pre-dose), Cycle 13 Day 1 (pre-dose) (each cycle = 21 days)

Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.

Cycle 1 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	NA	± NA

Cycle 1 Day 1 Post-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	62.35	± 26

Cycle 2 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	14.67	± 34

Cycle 5 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	33.34	± 22

Cycle 5 Day 1- Post-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	117.68	± 9

Cycle 6 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	36.41	± 4

Cycle 9 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	46.76	± 6

Cycle 13 Day 1- Pre-dose

Group	Value	95% CI
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)	48.30	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10]). Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg

Serious: 1/1 (100%)

Deaths: 0/1

Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg

Serious: 2/3 (67%)

Deaths: 0/3

Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg

Serious: 3/6 (50%)

Deaths: 4/6

Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg

Serious: 9/16 (56%)

Deaths: 7/16

Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg

Serious: 1/6 (17%)

Deaths: 2/6

Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)

Serious: 3/9 (33%)

Deaths: 4/9

Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)

Serious: 5/11 (45%)

Deaths: 3/11

Phase 1b: Dose Expansion: Cohort 1

Serious: 21/41 (51%)

Deaths: 24/41

Phase 1b: Dose Expansion: Cohort 2

Serious: 28/43 (65%)

Deaths: 24/43

Phase 1b: Dose Expansion: Cohort 3

Serious: 15/45 (33%)

Deaths: 22/45

Phase 1b: Dose Expansion: Cohort 4

Serious: 23/43 (53%)

Deaths: 35/43

Phase 1b: Dose Expansion: Cohort 5

Serious: 9/26 (35%)

Deaths: 18/26

Phase 1b: Dose Expansion: Cohort 6

Serious: 11/21 (52%)

Deaths: 14/21

Phase 1b: Dose Expansion: Cohort 7

Serious: 4/6 (67%)

Deaths: 6/6

Phase 1b: Dose Expansion: Cohort 8

Serious: 22/41 (54%)

Deaths: 19/41

Phase 1b: Dose Expansion: Cohort 9

Serious: 32/60 (53%)

Deaths: 42/60

Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)

Serious: 8/21 (38%)

Deaths: 8/21

Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)

Serious: 10/24 (42%)

Deaths: 9/24

Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)

Serious: 13/23 (57%)

Deaths: 10/23

Serious adverse events (187 terms)

Reaction	System	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Verification…	Phase 1: Dose Verification…	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Optimizatio…	Phase 1b: Dose Optimizatio…	Phase 1b: Dose Optimizatio…
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Large intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oesophageal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Death	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Immune-mediated hepatitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (378 terms — click to expand)

Reaction	System	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Escalation: …	Phase 1: Dose Verification…	Phase 1: Dose Verification…	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Expansion: …	Phase 1b: Dose Optimizatio…	Phase 1b: Dose Optimizatio…	Phase 1b: Dose Optimizatio…
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Ascites, Diarrhoea, Asthenia, Neutrophil count decreased, Immune-mediated lung disease, Obstructive airways disorder, Pleural effusion.

Data from ClinicalTrials.gov NCT04047862 adverse events section.

Sponsor's own description

The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1.

Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.

Publications & conference data

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

1. Exploring the NK cell platform for cancer immunotherapy.
   Myers JA, Miller JS. · · 2021 · cited 977× · PMID 32934330 · DOI 10.1038/s41571-020-0426-7
2. Regulatory T cells in tumor microenvironment: new mechanisms, potential therapeutic strategies and future prospects.
   Li C, Jiang P, Wei S, Xu X, et al · · 2020 · cited 679× · PMID 32680511 · DOI 10.1186/s12943-020-01234-1
3. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
4. Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy.
   Cai L, Li Y, Tan J, Xu L, et al · · 2023 · cited 232× · PMID 37670328 · DOI 10.1186/s13045-023-01499-1
5. Therapeutic targeting of regulatory T cells in cancer.
   Shan F, Somasundaram A, Bruno TC, Workman CJ, et al · · 2022 · cited 179× · PMID 35853825 · DOI 10.1016/j.trecan.2022.06.008
6. TIGIT, the Next Step Towards Successful Combination Immune Checkpoint Therapy in Cancer.
   Ge Z, Peppelenbosch MP, Sprengers D, Kwekkeboom J. · · 2021 · cited 166× · PMID 34367161 · DOI 10.3389/fimmu.2021.699895
7. Co-inhibition of TIGIT and PD-1/PD-L1 in Cancer Immunotherapy: Mechanisms and Clinical Trials.
   Chu X, Tian W, Wang Z, Zhang J, et al · · 2023 · cited 147× · PMID 37291608 · DOI 10.1186/s12943-023-01800-3
8. Natural killer cells: a promising immunotherapy for cancer.
   Chu J, Gao F, Yan M, Zhao S, et al · · 2022 · cited 140× · PMID 35606854 · DOI 10.1186/s12967-022-03437-0