18 and older, any sex, with Solid Tumors or Metastatic Melanoma. 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.
Part A: Number of Participants With a Dose-Limiting Toxicity (DLT)Primary· From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)
A DLT was defined as a clinically significant adverse event (AE) or significant laboratory abnormality: 1) occurring during DLT assessment period of 21 days; 2) considered to be related to study treatment RO7121661 by the Investigator; 3) is not attributed to disease progression or another clearly identifiable cause. Following AEs were considered DLTs: Hematological toxicities (Grade 4 neutropenia lasting \>5 days, Grade ≥3 febrile neutropenia, Grade 4 thrombocytopenia lasting \> 48 hours, Grade 3 thrombocytopenia associated with bleeding episodes, Grade 4 anemia, Grade ≥3 anemia with hemolysi
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0
Part A: Lomvastomig 210 mg
0
Part A: Lomvastomig 615 mg
0
Part A: Lomvastomig 1200 mg
1
Part A: Lomvastomig 1800 mg
0
Part A: Lomvastomig 2100 mg
0
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)Primary· From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months)
AE=any untoward medical occurrence in a participant administered a pharmaceutical product \& which does not necessarily have a causal relationship with treatment \& can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of pharmaceutical product, whether or not considered related to pharmaceutical product. Severity of AEs was graded as: Grade 1=Mild, asymptomatic/mild symptoms, clinical/diagnostic observations only, or intervention not indicated; Grade 2=Moderate, minimal, lo
AEs (Any grade)
Group
Value
95% CI
Part A: Lomvastomig 70 mg
3
Part A: Lomvastomig 210 mg
5
Part A: Lomvastomig 615 mg
4
Part A: Lomvastomig 1200 mg
4
Part A: Lomvastomig 1800 mg
3
Part A: Lomvastomig 2100 mg
18
Grade 1 AE
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0
Part A: Lomvastomig 210 mg
3
Part A: Lomvastomig 615 mg
1
Part A: Lomvastomig 1200 mg
0
Part A: Lomvastomig 1800 mg
0
Part A: Lomvastomig 2100 mg
2
Grade 2 AE
Group
Value
95% CI
Part A: Lomvastomig 70 mg
2
Part A: Lomvastomig 210 mg
1
Part A: Lomvastomig 615 mg
2
Part A: Lomvastomig 1200 mg
2
Part A: Lomvastomig 1800 mg
1
Part A: Lomvastomig 2100 mg
9
Grade 3 AE
Group
Value
95% CI
Part A: Lomvastomig 70 mg
1
Part A: Lomvastomig 210 mg
1
Part A: Lomvastomig 615 mg
1
Part A: Lomvastomig 1200 mg
1
Part A: Lomvastomig 1800 mg
2
Part A: Lomvastomig 2100 mg
7
Grade 4 AE
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0
Part A: Lomvastomig 210 mg
0
Part A: Lomvastomig 615 mg
0
Part A: Lomvastomig 1200 mg
1
Part A: Lomvastomig 1800 mg
0
Part A: Lomvastomig 2100 mg
0
Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)Primary· Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)
ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD.
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
7.9
2.19 – 19.16
Part B2: NSCLC Expansion Cohort 1
0
0.00 – 11.29
Part B4: SCLC Expansion Cohort
0
0.00 – 18.10
Part B5: ESCC Expansion Cohort
20.0
5.68 – 43.98
Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1Primary· Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)
DCR was defined as the percentage of participants with an objective tumor response of CR, PR or stable disease (SD) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD). PD was defined as at least a
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
36.8
23.83 – 51.47
Part B2: NSCLC Expansion Cohort 1
36.0
20.24 – 54.39
Part B4: SCLC Expansion Cohort
0
0.00 – 18.10
Part B5: ESCC Expansion Cohort
60.0
35.96 – 80.91
Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1Primary· From first occurrence of documented OR up to disease progression or death (Up to 43.3 months) (Cycle length = 14 days)
DOR was calculated for participants who had a best confirmed overall response (OR) of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death (within 30 days from last treatment) from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the bas
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
17.7
3.9 – NA
Part B5: ESCC Expansion Cohort
10.6
3.9 – NA
Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1Primary· From treatment initiation (Cycle 1 Day 1) until disease progression or death (Up to 43.3 months) (Cycle length= 14 days)
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the l
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
1.8
1.7 – 2.0
Part B2: NSCLC Expansion Cohort 1
1.7
1.6 – 1.9
Part B4: SCLC Expansion Cohort
1.7
1.6 – 1.8
Part B5: ESCC Expansion Cohort
3.6
1.5 – 5.7
Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)Secondary· Baseline and Day 1 of Cycles 1 to 5; Day 1 of Cycle 7, and every 6 cycles thereafter (1 cycle is 14 days); study completion/discontinuation; safety follow-up visits (up to approximately 40.8 months - Part A and 45.4 months - Part B)
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
Group
Value
95% CI
Part A: Lomvastomig 70 mg
3
Part A: Lomvastomig 210 mg
2
Part A: Lomvastomig 615 mg
0
Part A: Lomvastomig 1200 mg
0
Part A: Lomvastomig 1800 mg
1
Part A: Lomvastomig 2100 mg
3
Part B1: Metastatic Melanoma Expansion Cohort
5
Part B2: NSCLC Expansion Cohort 1
7
Part B4: SCLC Expansion Cohort
1
Part B5: ESCC Expansion Cohort
6
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral BloodSecondary· Days 1, 2, and 8 of Cycles 1 and 5; Day 1 of Cycles 2, 3, and 9 (1 cycle is 14 days); study completion visit (28 days after last dose; up to 43.3 months); safety follow-up (SFU) (90 days after last dose; up to 45.4 months)
Biomarker analyses were performed using peripheral blood samples that were collected from participants in Part B of the study. The blood samples were assessed by flow cytometry for absolute counts of CD3⁺CD8⁺ T cells and proliferating CD3⁺CD8⁺Ki67⁺ T cells.
CD3+CD8+: Cycle 1 Day 1
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
350.63
± 186.81
Part B2: NSCLC Expansion Cohort 1
293.25
± 137.62
Part B4: SCLC Expansion Cohort
252.60
± 224.48
Part B5: ESCC Expansion Cohort
256.00
± 138.59
CD3+CD8+: Cycle 1 Day 2
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
371.61
± 219.58
Part B2: NSCLC Expansion Cohort 1
317.28
± 175.47
Part B4: SCLC Expansion Cohort
296.20
± 519.44
Part B5: ESCC Expansion Cohort
306.50
± 111.02
CD3+CD8+: Cycle 1 Day 8
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
364.09
± 264.35
Part B2: NSCLC Expansion Cohort 1
342.59
± 223.74
Part B4: SCLC Expansion Cohort
292.47
± 349.48
Part B5: ESCC Expansion Cohort
329.00
± NA
CD3+CD8+: Cycle 2 Day 1
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
378.54
± 250.58
Part B2: NSCLC Expansion Cohort 1
298.91
± 153.88
Part B4: SCLC Expansion Cohort
245.93
± 226.21
Part B5: ESCC Expansion Cohort
257.00
± 66.47
CD3+CD8+: Cycle 3 Day 1
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
422.00
± 380.62
Part B2: NSCLC Expansion Cohort 1
310.47
± 171.87
Part B4: SCLC Expansion Cohort
193.18
± 81.24
Part B5: ESCC Expansion Cohort
199.00
± NA
CD3+CD8+: Cycle 5 Day 1
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
403.88
± 270.34
Part B2: NSCLC Expansion Cohort 1
269.00
± 106.32
Part B4: SCLC Expansion Cohort
234.00
± 72.48
CD3+CD8+: Cycle 5 Day 2
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
445.53
± 228.03
Part B2: NSCLC Expansion Cohort 1
285.71
± 120.35
Part B4: SCLC Expansion Cohort
260.50
± 59.52
CD3+CD8+: Cycle 5 Day 8
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
516.80
± 332.31
Part B2: NSCLC Expansion Cohort 1
267.57
± 116.42
Part B4: SCLC Expansion Cohort
179.00
± 68.02
Part B: Biomarkers: CD8+ T-cell Densities in Tumor BiopsiesSecondary· At screening and Cycle 3 Day 1
Fresh tumor biopsies were collected from participants in Part B of the study to assess changes in T-cell infiltration and activation within the tumor microenvironment. Tumor tissue was evaluated for CD8⁺ T-cell densities. The tumor tissue samples were collected at screening (archival metastasis and archival primary samples) and during the study (fresh samples).
Archival Metastasis Samples
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
215.16
± 319.52
Part B2: NSCLC Expansion Cohort 1
29.51
± NA
Archival Primary Samples
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
374.92
± 530.17
Part B2: NSCLC Expansion Cohort 1
764.26
± 470.25
Part B5: ESCC Expansion Cohort
275.02
± 347.75
Fresh Sample 1
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
1090.51
± 1001.71
Part B2: NSCLC Expansion Cohort 1
765.44
± 986.47
Part B4: SCLC Expansion Cohort
221.87
± 363.76
Part B5: ESCC Expansion Cohort
510.21
± 601.10
Fresh Sample 2
Group
Value
95% CI
Part B1: Metastatic Melanoma Expansion Cohort
912.58
± 1089.90
Part B2: NSCLC Expansion Cohort 1
790.76
± 462.38
Part B4: SCLC Expansion Cohort
288.21
± NA
Part B5: ESCC Expansion Cohort
322.23
± 256.74
Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of LomvastomigSecondary· Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Cycle 1
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0.09
0.09 – 0.17
Part A: Lomvastomig 210 mg
0.09
0.09 – 1
Part A: Lomvastomig 615 mg
0.125
0.09 – 0.17
Part A: Lomvastomig 1200 mg
0.17
0.09 – 0.26
Part A: Lomvastomig 1800 mg
0.17
0.17 – 0.25
Part A: Lomvastomig 2100 mg
0.09
0.09 – 0.19
Part A: Lomvastomig 2100 mg (Extension Cohort 1)
0.175
0.17 – 0.25
Part A: Lomvastomig 2100 mg (Extension Cohort 2)
0.18
0.09 – 0.28
Part B1: Metastatic Melanoma Expansion Cohort
0.17
0.04 – 1.24
Part B2: NSCLC Expansion Cohort 1
0.1
0.04 – 0.18
Part B4: SCLC Expansion Cohort
0.17
0.09 – 0.91
Part B5: ESCC Expansion Cohort
0.17
0.08 – 0.25
Cycle 5
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0.16
0.16 – 0.16
Part A: Lomvastomig 210 mg
0.17
0.09 – 0.25
Part A: Lomvastomig 615 mg
2.5
1 – 4.01
Part A: Lomvastomig 1200 mg
3.57
1.12 – 6.02
Part A: Lomvastomig 1800 mg
0.17
0.17 – 0.17
Part A: Lomvastomig 2100 mg
0.17
0.17 – 0.17
Part A: Lomvastomig 2100 mg (Extension Cohort 1)
0.21
0.09 – 0.22
Part A: Lomvastomig 2100 mg (Extension Cohort 2)
0.215
0.09 – 0.23
Part B1: Metastatic Melanoma Expansion Cohort
0.1
0 – 0.98
Part B2: NSCLC Expansion Cohort 1
0.1
0.02 – 3.13
Part B4: SCLC Expansion Cohort
0.11
0.03 – 0.11
Part B5: ESCC Expansion Cohort
0.1
0.01 – 0.88
Parts A and B: Maximum Observed Serum Concentration (Cmax) of LomvastomigSecondary· Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Cycle 1
Group
Value
95% CI
Part A: Lomvastomig 70 mg
21.5
± 40.0
Part A: Lomvastomig 210 mg
61.7
± 25.2
Part A: Lomvastomig 615 mg
148
± 18.5
Part A: Lomvastomig 1200 mg
408
± 5.7
Part A: Lomvastomig 1800 mg
530
± 20.8
Part A: Lomvastomig 2100 mg
518
± 8.8
Part A: Lomvastomig 2100 mg (Extension Cohort 1)
575
± 29.4
Part A: Lomvastomig 2100 mg (Extension Cohort 2)
740
± 14.4
Part B1: Metastatic Melanoma Expansion Cohort
791
± 43.3
Part B2: NSCLC Expansion Cohort 1
704
± 26.2
Part B4: SCLC Expansion Cohort
726
± 16.1
Part B5: ESCC Expansion Cohort
754
± 24.5
Cycle 5
Group
Value
95% CI
Part A: Lomvastomig 70 mg
20.2
± NA
Part A: Lomvastomig 210 mg
128
± 8.3
Part A: Lomvastomig 615 mg
116
± 116.9
Part A: Lomvastomig 1200 mg
546
± 14.8
Part A: Lomvastomig 1800 mg
781
± 30.8
Part A: Lomvastomig 2100 mg
1600
± NA
Part A: Lomvastomig 2100 mg (Extension Cohort 1)
1500
± 0.0
Part A: Lomvastomig 2100 mg (Extension Cohort 2)
1520
± 17.5
Part B1: Metastatic Melanoma Expansion Cohort
1420
± 32.6
Part B2: NSCLC Expansion Cohort 1
1270
± 33.1
Part B4: SCLC Expansion Cohort
1240
± 23.0
Part B5: ESCC Expansion Cohort
1280
± 25.7
Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of LomvastomigSecondary· Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Cycle 1
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0.307
± 40.0
Part A: Lomvastomig 210 mg
0.294
± 25.3
Part A: Lomvastomig 615 mg
0.24
± 18.5
Part A: Lomvastomig 1200 mg
0.34
± 5.7
Part A: Lomvastomig 1800 mg
0.295
± 20.9
Part A: Lomvastomig 2100 mg
0.246
± 8.8
Part A: Lomvastomig 2100 mg (Extension Cohort 1)
0.274
± 29.4
Part A: Lomvastomig 2100 mg (Extension Cohort 2)
0.352
± 14.3
Part B1: Metastatic Melanoma Expansion Cohort
0.377
± 43.2
Part B2: NSCLC Expansion Cohort 1
0.335
± 26.2
Part B4: SCLC Expansion Cohort
0.346
± 16.1
Part B5: ESCC Expansion Cohort
0.359
± 24.4
Cycle 5
Group
Value
95% CI
Part A: Lomvastomig 70 mg
0.777
± NA
Part A: Lomvastomig 210 mg
0.608
± 8.4
Part A: Lomvastomig 615 mg
0.188
± 117.0
Part A: Lomvastomig 1200 mg
0.455
± 14.8
Part A: Lomvastomig 1800 mg
0.434
± 30.8
Part A: Lomvastomig 2100 mg
0.762
± NA
Part A: Lomvastomig 2100 mg (Extension Cohort 1)
0.714
± 0.0
Part A: Lomvastomig 2100 mg (Extension Cohort 2)
0.725
± 17.5
Part B1: Metastatic Melanoma Expansion Cohort
0.675
± 32.6
Part B2: NSCLC Expansion Cohort 1
0.607
± 33.0
Part B4: SCLC Expansion Cohort
0.592
± 22.9
Part B5: ESCC Expansion Cohort
0.609
± 25.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part A: Lomvastomig 70mg
Serious: 1/3 (33%)
Deaths: 3/3
Part A: Lomvastomig 210 mg
Serious: 1/5 (20%)
Deaths: 3/5
Part A: Lomvastomig 615 mg
Serious: 1/4 (25%)
Deaths: 4/4
Part A: Lomvastomig 1200 mg
Serious: 1/4 (25%)
Deaths: 2/4
Part A: Lomvastomig 1800 mg
Serious: 1/4 (25%)
Deaths: 2/4
Part A: Lomvastomig 2100 mg
Serious: 7/19 (37%)
Deaths: 13/19
Part B1: Metastatic Melanoma Expansion Cohort
Serious: 6/38 (16%)
Deaths: 26/38
Part B2: NSCLC Expansion Cohort 1
Serious: 8/26 (31%)
Deaths: 18/26
Part B4: SCLC Expansion Cohort
Serious: 4/15 (27%)
Deaths: 13/15
Part B5: ESCC Expansion Cohort
Serious: 10/16 (63%)
Deaths: 8/16
Serious adverse events (50 terms)
Reaction
System
Part A: Lomvastomig 70mg
Part A: Lomvastomig 210 mg
Part A: Lomvastomig 615 mg
Part A: Lomvastomig 1200 mg
Part A: Lomvastomig 1800 mg
Part A: Lomvastomig 2100 mg
Part B1: Metastatic Melano…
Part B2: NSCLC Expansion C…
Part B4: SCLC Expansion Co…
Part B5: ESCC Expansion Co…
Pneumonia
Infections and infestations
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—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
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—
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—
—
Atrial fibrillation
Cardiac disorders
—
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—
—
—
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—
Retinopathy
Eye disorders
—
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Abdominal pain
Gastrointestinal disorders
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—
—
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Colitis
Gastrointestinal disorders
—
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—
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—
—
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Diarrhoea
Gastrointestinal disorders
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—
—
—
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—
—
Dysphagia
Gastrointestinal disorders
—
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—
—
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—
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—
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Gastric haemorrhage
Gastrointestinal disorders
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Haematemesis
Gastrointestinal disorders
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Intestinal obstruction
Gastrointestinal disorders
—
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Obstruction gastric
Gastrointestinal disorders
—
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Oesophageal stenosis
Gastrointestinal disorders
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Small intestinal perforation
Gastrointestinal disorders
—
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Bile duct stenosis
Hepatobiliary disorders
—
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Cholangitis
Hepatobiliary disorders
—
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—
—
—
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—
—
—
—
Cholecystitis
Hepatobiliary disorders
—
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—
—
—
—
—
—
—
—
Appendicitis perforated
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Bronchitis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Gallbladder abscess
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Phlebitis infective
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
False positive investigation result
Investigations
—
—
—
—
—
—
—
—
—
—
Other adverse events (181 terms — click to expand)
Reaction
System
Part A: Lomvastomig 70mg
Part A: Lomvastomig 210 mg
Part A: Lomvastomig 615 mg
Part A: Lomvastomig 1200 mg
Part A: Lomvastomig 1800 mg
Part A: Lomvastomig 2100 mg
Part B1: Metastatic Melano…
Part B2: NSCLC Expansion C…
Part B4: SCLC Expansion Co…
Part B5: ESCC Expansion Co…
Asthenia
General disorders
—
—
—
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
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—
—
—
—
—
—
—
—
Constipation
Gastrointestinal disorders
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—
—
—
—
—
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—
Fatigue
General disorders
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—
Arthralgia
Musculoskeletal and connective tissue disorders
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—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
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—
—
—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
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—
—
—
—
—
—
—
—
—
Oedema peripheral
General disorders
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—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
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—
—
—
—
—
—
—
—
—
Abdominal pain
Gastrointestinal disorders
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—
—
—
—
—
—
—
—
—
Weight decreased
Investigations
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—
—
—
—
—
—
Headache
Nervous system disorders
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—
—
—
—
—
—
—
—
Cough
Respiratory, thoracic and mediastinal disorders
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—
—
—
—
—
—
—
—
Pruritus
Skin and subcutaneous tissue disorders
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—
—
—
—
—
—
Urinary tract infection
Infections and infestations
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—
—
—
—
—
—
Aspartate aminotransferase increased
Investigations
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—
—
—
—
—
—
—
Hypokalaemia
Metabolism and nutrition disorders
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—
—
Hypophosphataemia
Metabolism and nutrition disorders
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Back pain
Musculoskeletal and connective tissue disorders
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—
Insomnia
Psychiatric disorders
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Lymphopenia
Blood and lymphatic system disorders
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—
—
—
—
—
Abdominal pain upper
Gastrointestinal disorders
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—
—
—
—
—
—
—
—
—
Dysphagia
Gastrointestinal disorders
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—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
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—
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—
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—
—
Alanine aminotransferase increased
Investigations
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—
—
—
—
—
—
—
Blood alkaline phosphatase increased
Investigations
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—
—
—
—
—
—
—
—
—
Gamma-glutamyltransferase increased
Investigations
—
—
—
—
—
—
—
—
—
—
Hypercalcaemia
Metabolism and nutrition disorders
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—
—
—
Hypoalbuminaemia
Metabolism and nutrition disorders
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—
—
—
—
—
—
—
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Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of lomvastomig. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of lomvastomig from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04785820 — A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or
· Phase 2
· completed
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Other Hoffmann-La Roche trials
Trials by the same sponsor.
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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 Hoffmann-La Roche
Last refreshed: 20 August 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/NCT03708328.