A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies
TerminatedPhase 1, PHASE2Results postedLast updated 2 April 2025
What this trial tests
Phase 1, PHASE2 trial testing Alomfilimab in Squamous Cell Carcinoma of Head and Neck in 222 participants. Terminated before completion.
18 and older, any sex, with Squamous Cell Carcinoma of Head and Neck or Non-small Cell Lung Cancer. 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 Experiencing Treatment-emergent Adverse Events (TEAEs)Primary· From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that:
* resulted in death;
* was life-threatening;
* resulted in inpatient hospitalization or prolongation of existing hospitalization;
* resulted in a persistent or significant disability/incapacity;
* resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;
* constituted an important medical event.
Clinically significant changes in lab
Any TEAEs
Group
Value
95% CI
Alomfilimab 0.8 mg
4
Alomfilimab 2.4 mg
4
Alomfilimab 8 mg
8
Alomfilimab 24 mg
7
Alomfilimab 80 mg
7
Alomfilimab 240 mg
5
Alomfilimab 0.8 mg + Atezolizumab
4
Alomfilimab 2.4 mg + Atezolizumab
43
Alomfilimab 8 mg + Atezolizumab
34
Alomfilimab 24 mg + Atezolizumab
9
Alomfilimab 80 mg + Atezolizumab
9
Any Serious TEAEs
Group
Value
95% CI
Alomfilimab 0.8 mg
1
Alomfilimab 2.4 mg
1
Alomfilimab 8 mg
3
Alomfilimab 24 mg
2
Alomfilimab 80 mg
3
Alomfilimab 240 mg
2
Alomfilimab 0.8 mg + Atezolizumab
2
Alomfilimab 2.4 mg + Atezolizumab
17
Alomfilimab 8 mg + Atezolizumab
11
Alomfilimab 24 mg + Atezolizumab
4
Alomfilimab 80 mg + Atezolizumab
3
Phase 1: Number of Participants Experiencing Dose ChangesPrimary· From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Dose changes were defined as infusion interruption and dose reduction.
Infusion Interruption
Group
Value
95% CI
Alomfilimab 0.8 mg
1
Alomfilimab 2.4 mg
0
Alomfilimab 8 mg
0
Alomfilimab 24 mg
1
Alomfilimab 80 mg
1
Alomfilimab 240 mg
0
Alomfilimab 0.8 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab
2
Alomfilimab 8 mg + Atezolizumab
0
Alomfilimab 24 mg + Atezolizumab
0
Alomfilimab 80 mg + Atezolizumab
2
Dose Reduction
Group
Value
95% CI
Alomfilimab 0.8 mg
0
Alomfilimab 2.4 mg
0
Alomfilimab 8 mg
0
Alomfilimab 24 mg
0
Alomfilimab 80 mg
0
Alomfilimab 240 mg
0
Alomfilimab 0.8 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab
0
Alomfilimab 8 mg + Atezolizumab
0
Alomfilimab 24 mg + Atezolizumab
0
Alomfilimab 80 mg + Atezolizumab
0
Phase 1: Absolute Dose IntensityPrimary· From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Group
Value
95% CI
Alomfilimab 0.8 mg
0.260
± 0.0000
Alomfilimab 2.4 mg
0.778
± 0.0179
Alomfilimab 8 mg
2.616
± 0.0427
Alomfilimab 24 mg
7.799
± 0.2694
Alomfilimab 80 mg
26.174
± 0.1952
Alomfilimab 240 mg
76.650
± 4.8260
Alomfilimab 0.8 mg + Atezolizumab
0.236
± 0.0288
Alomfilimab 2.4 mg + Atezolizumab
0.780
± 0.0176
Alomfilimab 8 mg + Atezolizumab
2.573
± 0.1159
Alomfilimab 24 mg + Atezolizumab
7.418
± 1.1455
Alomfilimab 80 mg + Atezolizumab
25.774
± 0.9037
Phase 1: Relative Dose IntensityPrimary· From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Group
Value
95% CI
Alomfilimab 0.8 mg
0.988
± 0.0189
Alomfilimab 2.4 mg
0.978
± 0.0179
Alomfilimab 8 mg
0.979
± 0.0179
Alomfilimab 24 mg
1.015
± 0.0835
Alomfilimab 80 mg
0.980
± 0.0058
Alomfilimab 240 mg
0.958
± 0.0610
Alomfilimab 0.8 mg + Atezolizumab
0.884
± 0.1071
Alomfilimab 2.4 mg + Atezolizumab
0.978
± 0.0202
Alomfilimab 8 mg + Atezolizumab
0.963
± 0.0432
Alomfilimab 24 mg + Atezolizumab
0.928
± 0.1422
Alomfilimab 80 mg + Atezolizumab
0.967
± 0.0316
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Primary· From first dose of study treatment (Day 1) up to 21 days
A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study.
Group
Value
95% CI
Alomfilimab 0.8 mg
0
Alomfilimab 2.4 mg
0
Alomfilimab 8 mg
0
Alomfilimab 24 mg
0
Alomfilimab 80 mg
0
Alomfilimab 240 mg
0
Alomfilimab 0.8 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab
0
Alomfilimab 8 mg + Atezolizumab
0
Alomfilimab 24 mg + Atezolizumab
0
Alomfilimab 80 mg + Atezolizumab
0
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1Primary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes m
Group
Value
95% CI
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
0
0.0 – 21.8
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
0
0.0 – 28.5
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
0
0.0 – 45.9
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
7.1
0.2 – 36.0
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
0
0.0 – 60.2
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
0
0.0 – 70.8
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
0
0.0 – 97.5
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
0
0.0 – 97.5
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
0
0.0 – 97.5
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
0
0.0 – 52.2
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
33.3
0.8 – 90.6
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
0
0.0 – 41.0
Best Overall Response (BOR) Per RECIST 1.1Secondary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of:
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference
Group
Value
95% CI
Alomfilimab 0.8 mg
0
Alomfilimab 2.4 mg
0
Alomfilimab 8 mg
0
Alomfilimab 24 mg
0
Alomfilimab 80 mg
0
Alomfilimab 240 mg
0
Alomfilimab 0.8 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab
1
Alomfilimab 8 mg + Atezolizumab
0
Alomfilimab 24 mg + Atezolizumab
0
Alomfilimab 80 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
0
Alomfilimab 0.8 mg
0
Alomfilimab 2.4 mg
0
Alomfilimab 8 mg
0
Alomfilimab 24 mg
0
Alomfilimab 80 mg
0
Alomfilimab 240 mg
0
Alomfilimab 0.8 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab
3
Alomfilimab 8 mg + Atezolizumab
2
Alomfilimab 24 mg + Atezolizumab
1
Alomfilimab 80 mg + Atezolizumab
0
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
0
Alomfilimab 0.8 mg
1
Alomfilimab 2.4 mg
0
Alomfilimab 8 mg
2
Alomfilimab 24 mg
2
Alomfilimab 80 mg
2
Alomfilimab 240 mg
1
Alomfilimab 0.8 mg + Atezolizumab
3
Alomfilimab 2.4 mg + Atezolizumab
12
Alomfilimab 8 mg + Atezolizumab
8
Alomfilimab 24 mg + Atezolizumab
1
Alomfilimab 80 mg + Atezolizumab
4
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
6
Alomfilimab 0.8 mg
3
Alomfilimab 2.4 mg
3
Alomfilimab 8 mg
7
Alomfilimab 24 mg
3
Alomfilimab 80 mg
4
Alomfilimab 240 mg
4
Alomfilimab 0.8 mg + Atezolizumab
1
Alomfilimab 2.4 mg + Atezolizumab
20
Alomfilimab 8 mg + Atezolizumab
22
Alomfilimab 24 mg + Atezolizumab
7
Alomfilimab 80 mg + Atezolizumab
2
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
9
Progression-free Survival (PFS) Per RECIST 1.1Secondary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were
Group
Value
95% CI
Alomfilimab 0.8 mg
2
2 – NA
Alomfilimab 2.4 mg
2
1 – NA
Alomfilimab 8 mg
2
1 – 6
Alomfilimab 24 mg
3
1 – NA
Alomfilimab 80 mg
2
1 – NA
Alomfilimab 240 mg
1
1 – NA
Alomfilimab 0.8 mg + Atezolizumab
3
2 – NA
Alomfilimab 2.4 mg + Atezolizumab
2
2 – 4
Alomfilimab 8 mg + Atezolizumab
2
2 – 2
Alomfilimab 24 mg + Atezolizumab
2
1 – 4
Alomfilimab 80 mg + Atezolizumab
4
2 – NA
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
2
1 – 4
Duration of Response Per RECIST 1.1Secondary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response \[CR or PR\] + 1\]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tum
Group
Value
95% CI
Alomfilimab 0.8 mg + Atezolizumab
11
NA – NA
Alomfilimab 2.4 mg + Atezolizumab
6
2.1 – NA
Alomfilimab 8 mg + Atezolizumab
NA
13.9 – NA
Alomfilimab 24 mg + Atezolizumab
11
NA – NA
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
2
NA – NA
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
13
NA – NA
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
NA
NA – NA
ORR Per iRECISTSecondary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson).
iCR: disappearance of all target and non-target lesions. Any pathological ly
Group
Value
95% CI
Alomfilimab 0.8 mg
0
0.0 – 60.2
Alomfilimab 2.4 mg
0
0.0 – 70.8
Alomfilimab 8 mg
0
0.0 – 33.6
Alomfilimab 24 mg
0
0.0 – 52.2
Alomfilimab 80 mg
0
0.0 – 45.9
Alomfilimab 240 mg
0
0.0 – 52.2
Alomfilimab 0.8 mg + Atezolizumab
0
0.0 – 60.2
Alomfilimab 2.4 mg + Atezolizumab
9.3
3.1 – 26.1
Alomfilimab 8 mg + Atezolizumab
5.6
0.8 – 21.4
Alomfilimab 24 mg + Atezolizumab
11.1
0.3 – 48.2
Alomfilimab 80 mg + Atezolizumab
0
0.0 – 45.9
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
0
0.0 – 23.2
PFS Per iRECISTSecondary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were
Group
Value
95% CI
Alomfilimab 0.8 mg
7
NA – NA
Alomfilimab 2.4 mg
10
4.2 – NA
Alomfilimab 8 mg
10
3.4 – NA
Alomfilimab 24 mg
6
3.3 – NA
Alomfilimab 80 mg
6
2.7 – NA
Alomfilimab 240 mg
6
3.4 – NA
Alomfilimab 0.8 mg + Atezolizumab
4
2.5 – NA
Alomfilimab 2.4 mg + Atezolizumab
7
5.5 – 10.0
Alomfilimab 8 mg + Atezolizumab
5
2.8 – 9.9
Alomfilimab 24 mg + Atezolizumab
3
1.8 – 4.0
Alomfilimab 80 mg + Atezolizumab
5
4.6 – NA
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
5
2.5 – NA
Phase 1: ORR Per RECIST 1.1Secondary· From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis).
Group
Value
95% CI
Alomfilimab 0.8 mg
0
0.0 – 60.2
Alomfilimab 2.4 mg
0
0.0 – 70.8
Alomfilimab 8 mg
0
0.0 – 33.6
Alomfilimab 24 mg
0
0.0 – 52.2
Alomfilimab 80 mg
0
0.0 – 45.9
Alomfilimab 240 mg
0
0.0 – 52.2
Alomfilimab 0.8 mg + Atezolizumab
0
0.0 – 60.2
Alomfilimab 2.4 mg + Atezolizumab
9.3
3.1 – 26.1
Alomfilimab 8 mg + Atezolizumab
5.6
0.8 – 20.8
Alomfilimab 24 mg + Atezolizumab
11.1
0.3 – 48.2
Alomfilimab 80 mg + Atezolizumab
0
0.0 – 45.9
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Alomfilimab 0.8 mg
Serious: 1/4 (25%)
Deaths: 2/4
Alomfilimab 2.4 mg
Serious: 1/5 (20%)
Deaths: 4/5
Alomfilimab 8 mg
Serious: 3/10 (30%)
Deaths: 5/9
Alomfilimab 24 mg
Serious: 2/8 (25%)
Deaths: 7/8
Alomfilimab 80 mg
Serious: 3/7 (43%)
Deaths: 5/7
Alomfilimab 240 mg
Serious: 2/5 (40%)
Deaths: 4/5
Alomfilimab 0.8 mg + Atezolizumab
Serious: 2/5 (40%)
Deaths: 5/5
Alomfilimab 2.4 mg + Atezolizumab
Serious: 17/43 (40%)
Deaths: 24/43
Alomfilimab 8 mg + Atezolizumab
Serious: 11/35 (31%)
Deaths: 22/36
Alomfilimab 24 mg + Atezolizumab
Serious: 4/9 (44%)
Deaths: 6/9
Alomfilimab 80 mg + Atezolizumab
Serious: 3/9 (33%)
Deaths: 3/9
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Serious: 6/15 (40%)
Deaths: 10/15
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Serious: 2/14 (14%)
Deaths: 10/14
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Serious: 1/7 (14%)
Deaths: 5/7
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Serious: 2/14 (14%)
Deaths: 7/14
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Serious: 1/5 (20%)
Deaths: 3/5
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Serious: 1/5 (20%)
Deaths: 2/5
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Serious: 1/2 (50%)
Deaths: 1/2
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Serious: 0/1 (0%)
Deaths: 1/1
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Serious: 0/1 (0%)
Deaths: 1/1
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Serious: 2/6 (33%)
Deaths: 1/6
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Serious: 1/3 (33%)
Deaths: 2/3
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Serious: 4/8 (50%)
Deaths: 4/9
Serious adverse events (77 terms)
Reaction
System
Alomfilimab 0.8 mg
Alomfilimab 2.4 mg
Alomfilimab 8 mg
Alomfilimab 24 mg
Alomfilimab 80 mg
Alomfilimab 240 mg
Alomfilimab 0.8 mg + Atezo…
Alomfilimab 2.4 mg + Atezo…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 24 mg + Atezol…
Alomfilimab 80 mg + Atezol…
Alomfilimab 2.4 mg + Atezo…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 2.4 mg + Atezo…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 24 mg + Atezol…
Alomfilimab 2.4 mg + Atezo…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 2.4 mg + Atezo…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 8 mg + Atezoli…
Alomfilimab 24 mg + Atezol…
Abdominal pain
Gastrointestinal disorders
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Dysphagia
Gastrointestinal disorders
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Pneumonia
Infections and infestations
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Blood bilirubin increased
Investigations
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Back pain
Musculoskeletal and connective tissue disorders
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Pleural effusion
Respiratory, thoracic and mediastinal disorders
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Anaemia
Blood and lymphatic system disorders
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Atrial fibrillation
Cardiac disorders
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Inappropriate antidiuretic hormone secretion
Endocrine disorders
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Ascites
Gastrointestinal disorders
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Mouth haemorrhage
Gastrointestinal disorders
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Nausea
Gastrointestinal disorders
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Obstruction gastric
Gastrointestinal disorders
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Odynophagia
Gastrointestinal disorders
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Oesophageal haemorrhage
Gastrointestinal disorders
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Oesophageal stenosis
Gastrointestinal disorders
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Small intestinal obstruction
Gastrointestinal disorders
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Upper gastrointestinal haemorrhage
Gastrointestinal disorders
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Vomiting
Gastrointestinal disorders
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Chest pain
General disorders
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Chills
General disorders
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Death
General disorders
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Face oedema
General disorders
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Fatigue
General disorders
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Medical device discomfort
General disorders
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Other adverse events (232 terms — click to expand)
A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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· recruiting
NCT07276399 — A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurre
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· recruiting
NCT07063212 — A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
· Phase 2
· recruiting
NCT06487403 — HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune R
· NA
· recruiting
Other Kymab Limited trials
Trials by the same sponsor.
NCT05131477 — Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
· Phase 2
· completed
NCT04449939 — A Study of Subcutaneous KY1005 in Healthy Volunteers
· Phase 1
· completed
NCT03754309 — A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis
· Phase 2
· completed
NCT03161288 — A Study of KY1005 in Healthy Volunteers
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kymab Limited
Last refreshed: 2 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03829501.