Esophageal Squamous Cell Carcinoma (ESCC), Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGLomvastomig
Lomvastomig will be administered intravenously (IV) with a flat dose on the schedule described for each study arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Part A: Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient * Eastern Cooperative Oncology Group Performance Status 0-1 * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) * Fresh biopsies may be required * Negative HIV, hepatitis B, or hepatitis C test result * Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol Additional Specific Inclusion Criteria for Participants with Melanoma: * Histologically confirmed, unresectable stage III or stage IV melanoma * Previously treated with approved anti-programmed death-ligand 1 (PD-L1)/anti-programmed death-1 (PD-1) agents with or without approved anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy and up to one additional treatment regimen Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Received Treatment for Metastatic Disease: * Histologically confirmed advanced NSCLC * Previously treated with approved PD-L1/PD-1 inhibitors and platinum-based chemotherapy * Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling to the study * Participants must have experienced initial clinical benefit (stable disease or better) from most recent checkpoint inhibitor (CPI) therapy * Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Did Not Receive Treatment for Metastatic Disease: * Histologically confirmed advanced NSCLC * Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening Additional Specific Inclusion Criteria for Participants with Small Cell Lung Cancer (SCLC): * Histologically confirmed SCLC * Participants may have had prior chemotherapy, radiation therapy, or declined approved therapies for SCLC Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC): * Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus * Patients who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling to the study
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 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 hemolysis); Non-hematological toxicity Grade ≥3 (Any Grade 3 immune-mediated AE, Grade 3 hyperbilirubinemia lasting for \>48 hours/Grade 4 hyperbilirubinemia; Grade ≥3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations with hyperbilirubinemia of Grade ≥2, Grade 4 AST or ALT elevations, Grade ≥3 nausea, vomiting, or diarrhea, Grade ≥3 non-hematological laboratory abnormality. |
| 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) | 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, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. |
| Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 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. |
| Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1 | 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 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1 | 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 baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). 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 last tumor assessment. |
| Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1 | 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 last tumor assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | 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) | For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle. |
| Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | 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) | For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle. |
| Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | 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) | For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle. |
| Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | 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) | — |
| Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | Predose and EOI: Day 1 of Cycles 1 and 5; Predose: Day 1 of Cycles 2, 3, and 9; Postdose: Day 8 of Cycles 1 and 5 (1 cycle is 14 days); study completion (28 days after last dose; up to 39.7 months); SFU (60 days after last dose; up to 40.8 months) | Blood samples were collected from participants in Part A of the study and different types of immune cells were assessed by flow cytometry for the percentage of receptor occupancy (RO) by lomvastomig. RO (or drug coverage) is used to quantify the binding of the therapeutic to its target on the cell surface. The RO of lomvastomig was determined on cells that were positive (+) for CD3+, CD4+, CD56+/16+, and CD8+. |
| Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 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). |
| Part A: ORR as Determined by Investigator Using RECIST v1.1 | 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 39.7 months) (Cycle length= 14 days) | ORR was defined as the percentage of participants with an objective tumor response of CR or 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 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. |
| Part A: DCR as Determined by Investigator Using RECIST v1.1 | 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 39.7 months) (Cycle length= 14 days) | DCR was defined as the percentage of participants with an objective tumor response of CR, PR or 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 PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Part A: DOR as Determined by Investigator Using RECIST v1.1 | From first occurrence of documented OR up to disease progression or death (Up to 39.7 months) (Cycle length= 14 days) | DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=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=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). 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 from any cause as of the data cut-off date were censored at the time of the last tumor assessment. |
| Part A: PFS as Determined by Investigator Using RECIST v1.1 | From initiation of study treatment (Cycle 1 Day 1) until disease progression or death (Up to 39.7 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 last tumor assessment. |
| Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 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, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. |
| Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | 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. |
| Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | 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). |
| Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | 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) | — |
| Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | 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) | — |
| Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | 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) | — |
Countries
Denmark, France, New Zealand, South Korea, Spain, United States
Participant flow
Recruitment details
A total of 134 participants with advanced and/or metastatic solid tumors took part in the study across 17 investigative sites in Spain, France, Republic of Korea, Denmark, United States and New Zealand from 15 October 2018 to 09 July 2024.
Pre-assignment details
This study was conducted in two parts: Part A (Dose Escalation) and Part B (Tumor-Specific Expansion Cohorts). Part B included the Cohorts B1, B2, B4, and B5, enrolling participants with selected tumor types. Part B3 was not initiated.
Participants by arm
| Arm | Count |
|---|---|
| Part A: Lomvastomig 70 mg Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 3 |
| Part A: Lomvastomig 210 mg Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 5 |
| Part A: Lomvastomig 615 mg Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 4 |
| Part A: Lomvastomig 1200 mg Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 4 |
| Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 4 |
| Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 19 |
| Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 38 |
| Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 26 |
| Part B4: SCLC Expansion Cohort Participants with CPI-naïve SCLC with prior failure of, progression on, or intolerance to standard therapy received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 15 |
| Part B5: ESCC Expansion Cohort Participants with CPI-naïve ESCC received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days). | 16 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 3 | 3 | 4 | 2 | 2 | 13 | 26 | 18 | 13 | 8 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 | 3 | 3 | 0 | 0 | 1 |
| Overall Study | Participant Was Alive, Did Not Return to Hospital | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Study Closed Locally | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Study Ended By Sponsor | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 4 | 1 | 5 |
Baseline characteristics
| Characteristic | Part A: Lomvastomig 70 mg | 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 Melanoma Expansion Cohort | Part B2: NSCLC Expansion Cohort 1 | Part B4: SCLC Expansion Cohort | Part B5: ESCC Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 9.3 | 59.6 years STANDARD_DEVIATION 13.9 | 61.0 years STANDARD_DEVIATION 2.4 | 53.8 years STANDARD_DEVIATION 7.1 | 53.5 years STANDARD_DEVIATION 15.8 | 60.9 years STANDARD_DEVIATION 8.8 | 61.1 years STANDARD_DEVIATION 12.1 | 62.3 years STANDARD_DEVIATION 9.7 | 60.3 years STANDARD_DEVIATION 9.2 | 61.1 years STANDARD_DEVIATION 10.6 | 60.6 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants | 2 Participants | 4 Participants | 17 Participants | 28 Participants | 20 Participants | 15 Participants | 8 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 9 Participants | 6 Participants | 0 Participants | 8 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 8 Participants | 2 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 3 Participants | 0 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 18 Participants | 28 Participants | 14 Participants | 13 Participants | 4 Participants | 97 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 9 Participants | 17 Participants | 11 Participants | 1 Participants | 4 Participants | 49 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 10 Participants | 21 Participants | 15 Participants | 14 Participants | 12 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 3 / 5 | 4 / 4 | 2 / 4 | 2 / 4 | 13 / 19 | 26 / 38 | 18 / 26 | 13 / 15 | 8 / 16 |
| other Total, other adverse events | 3 / 3 | 5 / 5 | 4 / 4 | 4 / 4 | 3 / 4 | 17 / 19 | 34 / 38 | 24 / 26 | 15 / 15 | 16 / 16 |
| serious Total, serious adverse events | 1 / 3 | 1 / 5 | 1 / 4 | 1 / 4 | 1 / 4 | 7 / 19 | 6 / 38 | 8 / 26 | 4 / 15 | 10 / 16 |
Outcome results
Primary
Part A: Number of Participants With a Dose-Limiting Toxicity (DLT)
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 hemolysis); Non-hematological toxicity Grade ≥3 (Any Grade 3 immune-mediated AE, Grade 3 hyperbilirubinemia lasting for \>48 hours/Grade 4 hyperbilirubinemia; Grade ≥3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations with hyperbilirubinemia of Grade ≥2, Grade 4 AST or ALT elevations, Grade ≥3 nausea, vomiting, or diarrhea, Grade ≥3 non-hematological laboratory abnormality.
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)
Population: The DLT-evaluable population included all participants in Part A who received at least two doses of study medication and either experienced a DLT within the DLT period or cleared the DLT period without a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Lomvastomig 70 mg | Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 0 Participants |
| Part A: Lomvastomig 210 mg | Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 0 Participants |
| Part A: Lomvastomig 615 mg | Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 0 Participants |
| Part A: Lomvastomig 1200 mg | Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 1 Participants |
| Part A: Lomvastomig 1800 mg | Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 0 Participants |
| Part A: Lomvastomig 2100 mg | Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) | 0 Participants |
Primary
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)
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, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.
Time frame: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months)
Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | 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) | Grade 3 AE | 1 Participants |
| Part A: Lomvastomig 70 mg | 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) | Grade 1 AE | 0 Participants |
| Part A: Lomvastomig 70 mg | 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) | AEs (Any grade) | 3 Participants |
| Part A: Lomvastomig 70 mg | 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) | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 70 mg | 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) | Grade 2 AE | 2 Participants |
| Part A: Lomvastomig 210 mg | 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) | Grade 1 AE | 3 Participants |
| Part A: Lomvastomig 210 mg | 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) | Grade 3 AE | 1 Participants |
| Part A: Lomvastomig 210 mg | 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) | AEs (Any grade) | 5 Participants |
| Part A: Lomvastomig 210 mg | 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) | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 210 mg | 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) | Grade 2 AE | 1 Participants |
| Part A: Lomvastomig 615 mg | 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) | Grade 1 AE | 1 Participants |
| Part A: Lomvastomig 615 mg | 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) | Grade 3 AE | 1 Participants |
| Part A: Lomvastomig 615 mg | 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) | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 615 mg | 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) | Grade 2 AE | 2 Participants |
| Part A: Lomvastomig 615 mg | 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) | AEs (Any grade) | 4 Participants |
| Part A: Lomvastomig 1200 mg | 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) | Grade 2 AE | 2 Participants |
| Part A: Lomvastomig 1200 mg | 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) | AEs (Any grade) | 4 Participants |
| Part A: Lomvastomig 1200 mg | 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) | Grade 1 AE | 0 Participants |
| Part A: Lomvastomig 1200 mg | 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) | Grade 3 AE | 1 Participants |
| Part A: Lomvastomig 1200 mg | 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) | Grade 4 AE | 1 Participants |
| Part A: Lomvastomig 1800 mg | 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) | Grade 3 AE | 2 Participants |
| Part A: Lomvastomig 1800 mg | 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) | AEs (Any grade) | 3 Participants |
| Part A: Lomvastomig 1800 mg | 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) | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 1800 mg | 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) | Grade 1 AE | 0 Participants |
| Part A: Lomvastomig 1800 mg | 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) | Grade 2 AE | 1 Participants |
| Part A: Lomvastomig 2100 mg | 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) | AEs (Any grade) | 18 Participants |
| Part A: Lomvastomig 2100 mg | 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) | Grade 3 AE | 7 Participants |
| Part A: Lomvastomig 2100 mg | 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) | Grade 1 AE | 2 Participants |
| Part A: Lomvastomig 2100 mg | 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) | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 2100 mg | 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) | Grade 2 AE | 9 Participants |
Primary
Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1
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 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: 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)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1 | 36.8 percentage of participants | 90% Confidence Interval 23.83 |
| Part A: Lomvastomig 210 mg | Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1 | 36.0 percentage of participants | 90% Confidence Interval 20.24 |
| Part A: Lomvastomig 615 mg | Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 1200 mg | Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1 | 60.0 percentage of participants | 90% Confidence Interval 35.96 |
Primary
Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1
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 baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). 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 last tumor assessment.
Time frame: From first occurrence of documented OR up to disease progression or death (Up to 43.3 months) (Cycle length = 14 days)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment. Overall number analyzed is the number of participants with OR, i.e., responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1 | 17.7 months |
| Part A: Lomvastomig 1200 mg | Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1 | 10.6 months |
Primary
Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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.
Time frame: 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)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 7.9 percentage of participants | 90% Confidence Interval 2.19 |
| Part A: Lomvastomig 210 mg | Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 615 mg | Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 1200 mg | Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 20.0 percentage of participants | 90% Confidence Interval 5.68 |
Primary
Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1
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 last tumor assessment.
Time frame: From treatment initiation (Cycle 1 Day 1) until disease progression or death (Up to 43.3 months) (Cycle length= 14 days)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1 | 1.8 months | 90% Confidence Interval 1.7 |
| Part A: Lomvastomig 210 mg | Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1 | 1.7 months | 90% Confidence Interval 1.6 |
| Part A: Lomvastomig 615 mg | Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1 | 1.7 months | 90% Confidence Interval 1.6 |
| Part A: Lomvastomig 1200 mg | Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1 | 3.6 months | 90% Confidence Interval 1.5 |
Secondary
Part A: DCR as Determined by Investigator Using RECIST v1.1
DCR was defined as the percentage of participants with an objective tumor response of CR, PR or 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 PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: 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 39.7 months) (Cycle length= 14 days)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Lomvastomig 70 mg | Part A: DCR as Determined by Investigator Using RECIST v1.1 | 33.3 percentage of participants |
| Part A: Lomvastomig 210 mg | Part A: DCR as Determined by Investigator Using RECIST v1.1 | 40.0 percentage of participants |
| Part A: Lomvastomig 615 mg | Part A: DCR as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants |
| Part A: Lomvastomig 1200 mg | Part A: DCR as Determined by Investigator Using RECIST v1.1 | 50.0 percentage of participants |
| Part A: Lomvastomig 1800 mg | Part A: DCR as Determined by Investigator Using RECIST v1.1 | 25.0 percentage of participants |
| Part A: Lomvastomig 2100 mg | Part A: DCR as Determined by Investigator Using RECIST v1.1 | 42.1 percentage of participants |
Secondary
Part A: DOR as Determined by Investigator Using RECIST v1.1
DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=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=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). 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 from any cause as of the data cut-off date were censored at the time of the last tumor assessment.
Time frame: From first occurrence of documented OR up to disease progression or death (Up to 39.7 months) (Cycle length= 14 days)
Population: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment. Overall number analyzed included participants with OR i.e., responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Lomvastomig 2100 mg | Part A: DOR as Determined by Investigator Using RECIST v1.1 | 13.8 months |
Secondary
Part A: ORR as Determined by Investigator Using RECIST v1.1
ORR was defined as the percentage of participants with an objective tumor response of CR or 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 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
Time frame: 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 39.7 months) (Cycle length= 14 days)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part A: ORR as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 210 mg | Part A: ORR as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 615 mg | Part A: ORR as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 1200 mg | Part A: ORR as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 1800 mg | Part A: ORR as Determined by Investigator Using RECIST v1.1 | 0 percentage of participants | 90% Confidence Interval 0 |
| Part A: Lomvastomig 2100 mg | Part A: ORR as Determined by Investigator Using RECIST v1.1 | 21.1 percentage of participants | 90% Confidence Interval 7.53 |
Secondary
Part A: PFS as Determined by Investigator Using RECIST v1.1
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 last tumor assessment.
Time frame: From initiation of study treatment (Cycle 1 Day 1) until disease progression or death (Up to 39.7 months) (Cycle length= 14 days)
Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Lomvastomig 70 mg | Part A: PFS as Determined by Investigator Using RECIST v1.1 | 1.8 months |
| Part A: Lomvastomig 210 mg | Part A: PFS as Determined by Investigator Using RECIST v1.1 | 2.0 months |
| Part A: Lomvastomig 615 mg | Part A: PFS as Determined by Investigator Using RECIST v1.1 | 1.6 months |
| Part A: Lomvastomig 1200 mg | Part A: PFS as Determined by Investigator Using RECIST v1.1 | NA months |
| Part A: Lomvastomig 1800 mg | Part A: PFS as Determined by Investigator Using RECIST v1.1 | 1.8 months |
| Part A: Lomvastomig 2100 mg | Part A: PFS as Determined by Investigator Using RECIST v1.1 | 1.9 months |
Secondary
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay
Blood samples were collected from participants in Part A of the study and different types of immune cells were assessed by flow cytometry for the percentage of receptor occupancy (RO) by lomvastomig. RO (or drug coverage) is used to quantify the binding of the therapeutic to its target on the cell surface. The RO of lomvastomig was determined on cells that were positive (+) for CD3+, CD4+, CD56+/16+, and CD8+.
Time frame: Predose and EOI: Day 1 of Cycles 1 and 5; Predose: Day 1 of Cycles 2, 3, and 9; Postdose: Day 8 of Cycles 1 and 5 (1 cycle is 14 days); study completion (28 days after last dose; up to 39.7 months); SFU (60 days after last dose; up to 40.8 months)
Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 5 Day 1 | 100.00 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Study Completion | 86.35 percent occupancy | Standard Deviation 7.71 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 5 Day 1 | 82.60 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: SFU | 98.70 percent occupancy | Standard Deviation 1.84 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 9 Day 1 | 117.90 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 5 Day 8 | 206.70 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 5 Day 8 | 3000.00 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 1 Day 8 | 97.65 percent occupancy | Standard Deviation 16.48 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Study Completion | 87.05 percent occupancy | Standard Deviation 8.7 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 5 Day 1 | 73.90 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 2 Day 1 | 98.77 percent occupancy | Standard Deviation 16.42 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 1 Day 8 | 98.43 percent occupancy | Standard Deviation 56.8 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 1 Day 1 | 86.80 percent occupancy | Standard Deviation 29.86 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 3 Day 1 | 94.40 percent occupancy | Standard Deviation 3.82 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 1 Day 1 | 39.93 percent occupancy | Standard Deviation 29.46 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Study Completion | 86.45 percent occupancy | Standard Deviation 19.16 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 5 Day 1 | 68.60 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: SFU | 108.75 percent occupancy | Standard Deviation 7.85 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 5 Day 1 | 103.10 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 2 Day 1 | 100.00 percent occupancy | Standard Deviation 0 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 9 Day 1 | 118.50 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 5 Day 8 | 305.30 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 5 Day 1 | 146.70 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 1 Day 1 | 57.53 percent occupancy | Standard Deviation 49.85 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 5 Day 1 | 75.00 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 9 Day 1 | 108.20 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 5 Day 1 | 42.90 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 1 Day 1 | 41.80 percent occupancy | Standard Deviation 37.87 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 3 Day 1 | 109.13 percent occupancy | Standard Deviation 22.69 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 1 Day 1 | 70.43 percent occupancy | Standard Deviation 46.32 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 2 Day 1 | 113.70 percent occupancy | Standard Deviation 2.36 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 1 Day 8 | 108.47 percent occupancy | Standard Deviation 4.5 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 3 Day 1 | 20.00 percent occupancy | Standard Deviation 28.28 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 1 Day 8 | 109.03 percent occupancy | Standard Deviation 9.42 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 1 Day 1 | 74.37 percent occupancy | Standard Deviation 44.3 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 2 Day 1 | 105.13 percent occupancy | Standard Deviation 9.63 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 9 Day 1 | 194.10 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 1 Day 1 | 36.37 percent occupancy | Standard Deviation 40.21 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 3 Day 1 | 100.33 percent occupancy | Standard Deviation 8.21 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 1 Day 1 | 68.60 percent occupancy | Standard Deviation 47.94 |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: SFU | 88.00 percent occupancy | — |
| Part A: Lomvastomig 70 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+:Predose on Cycle 5 Day 1 | 62.10 percent occupancy | — |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 2 Day 1 | 95.95 percent occupancy | Standard Deviation 3.72 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 1 Day 1 | 37.77 percent occupancy | Standard Deviation 32.4 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Study Completion | 88.93 percent occupancy | Standard Deviation 6.9 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 5 Day 8 | 89.33 percent occupancy | Standard Deviation 10.45 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: SFU | 128.10 percent occupancy | Standard Deviation 18.38 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 2 Day 1 | 95.53 percent occupancy | Standard Deviation 4.74 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 5 Day 1 | 95.23 percent occupancy | Standard Deviation 16.77 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 5 Day 8 | 108.97 percent occupancy | Standard Deviation 15.53 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 1 Day 8 | 97.48 percent occupancy | Standard Deviation 10.55 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 9 Day 1 | 92.45 percent occupancy | Standard Deviation 6.58 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 5 Day 1 | 95.60 percent occupancy | Standard Deviation 11.36 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 3 Day 1 | 90.62 percent occupancy | Standard Deviation 9.67 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 5 Day 8 | 93.17 percent occupancy | Standard Deviation 12.72 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 5 Day 1 | 100.17 percent occupancy | Standard Deviation 8.18 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 5 Day 1 | 73.33 percent occupancy | Standard Deviation 64.07 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 1 Day 8 | 99.03 percent occupancy | Standard Deviation 14.31 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 1 Day 8 | 101.40 percent occupancy | Standard Deviation 16.85 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 1 Day 1 | 36.23 percent occupancy | Standard Deviation 23.99 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 9 Day 1 | 93.55 percent occupancy | Standard Deviation 15.06 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 5 Day 1 | 82.10 percent occupancy | Standard Deviation 21.67 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+:Predose on Cycle 5 Day 1 | 100.20 percent occupancy | Standard Deviation 5.1 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 5 Day 1 | 100.67 percent occupancy | Standard Deviation 1.15 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 2 Day 1 | 94.28 percent occupancy | Standard Deviation 5.71 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 1 Day 1 | 92.28 percent occupancy | Standard Deviation 5.74 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 3 Day 1 | 60.76 percent occupancy | Standard Deviation 36.97 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 1 Day 1 | 100.32 percent occupancy | Standard Deviation 22.37 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 1 Day 1 | 95.60 percent occupancy | Standard Deviation 4.75 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 1 Day 1 | 36.23 percent occupancy | Standard Deviation 26.52 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 3 Day 1 | 93.38 percent occupancy | Standard Deviation 7.51 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 2 Day 1 | 89.10 percent occupancy | Standard Deviation 3.99 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Study Completion | 91.00 percent occupancy | Standard Deviation 23.91 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 3 Day 1 | 88.66 percent occupancy | Standard Deviation 11.84 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 1 Day 1 | 88.43 percent occupancy | Standard Deviation 37.59 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Study Completion | 95.07 percent occupancy | Standard Deviation 4.6 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 5 Day 1 | 96.27 percent occupancy | Standard Deviation 7.48 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 1 Day 8 | 123.60 percent occupancy | Standard Deviation 49.67 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: SFU | 134.55 percent occupancy | Standard Deviation 0.78 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: SFU | 129.45 percent occupancy | Standard Deviation 31.47 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 9 Day 1 | 101.25 percent occupancy | Standard Deviation 1.77 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 1 Day 1 | 93.22 percent occupancy | Standard Deviation 3.03 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 5 Day 1 | 91.80 percent occupancy | Standard Deviation 18.83 |
| Part A: Lomvastomig 210 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 9 Day 1 | 25.00 percent occupancy | Standard Deviation 35.36 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 3 Day 1 | 60.60 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 1 Day 1 | 107.58 percent occupancy | Standard Deviation 3.57 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 1 Day 8 | 106.53 percent occupancy | Standard Deviation 21.55 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 2 Day 1 | 97.23 percent occupancy | Standard Deviation 10.71 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 5 Day 1 | 144.70 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 5 Day 1 | 130.30 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 1 Day 1 | 34.77 percent occupancy | Standard Deviation 7.79 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 1 Day 1 | 106.48 percent occupancy | Standard Deviation 5.25 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 1 Day 8 | 105.33 percent occupancy | Standard Deviation 19.23 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 2 Day 1 | 92.80 percent occupancy | Standard Deviation 15.65 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 3 Day 1 | 52.20 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+:Predose on Cycle 5 Day 1 | 124.10 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 5 Day 1 | 128.60 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Study Completion | 94.75 percent occupancy | Standard Deviation 21.57 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 1 Day 1 | 30.07 percent occupancy | Standard Deviation 1.95 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Study Completion | 98.40 percent occupancy | Standard Deviation 24.04 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 1 Day 1 | 53.37 percent occupancy | Standard Deviation 18.41 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 1 Day 1 | 106.88 percent occupancy | Standard Deviation 11.27 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 1 Day 8 | 107.10 percent occupancy | Standard Deviation 19.15 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 2 Day 1 | 95.13 percent occupancy | Standard Deviation 27.8 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 3 Day 1 | 58.30 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 5 Day 1 | 110.50 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 5 Day 1 | 117.60 percent occupancy | — |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 1 Day 1 | 88.87 percent occupancy | Standard Deviation 11.2 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Study Completion | 103.00 percent occupancy | Standard Deviation 26.02 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 1 Day 1 | 107.25 percent occupancy | Standard Deviation 10.7 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 1 Day 8 | 90.18 percent occupancy | Standard Deviation 9.67 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 2 Day 1 | 47.83 percent occupancy | Standard Deviation 36.63 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 3 Day 1 | 42.40 percent occupancy | Standard Deviation 59.96 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 5 Day 1 | 50.80 percent occupancy | Standard Deviation 5.23 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 5 Day 1 | 32.15 percent occupancy | Standard Deviation 25.24 |
| Part A: Lomvastomig 615 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 5 Day 8 | 0.00 percent occupancy | Standard Deviation 0 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 5 Day 1 | 25.00 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 3 Day 1 | 90.00 percent occupancy | Standard Deviation 9.48 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Study Completion | 97.65 percent occupancy | Standard Deviation 7.99 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 9 Day 1 | 105.10 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: SFU | 94.60 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 5 Day 1 | 115.20 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 5 Day 8 | 96.95 percent occupancy | Standard Deviation 4.31 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 1 Day 1 | 37.73 percent occupancy | Standard Deviation 65.36 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: SFU | 93.90 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Study Completion | 98.95 percent occupancy | Standard Deviation 9.69 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 2 Day 1 | 93.17 percent occupancy | Standard Deviation 4.25 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 5 Day 1 | 165.50 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 9 Day 1 | 94.40 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 5 Day 1 | 94.30 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+:Predose on Cycle 5 Day 1 | 140.50 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 5 Day 1 | 97.60 percent occupancy | Standard Deviation 8.77 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 5 Day 1 | 114.60 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 5 Day 8 | 92.55 percent occupancy | Standard Deviation 4.17 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 1 Day 1 | 0.00 percent occupancy | Standard Deviation 0 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 3 Day 1 | 55.35 percent occupancy | Standard Deviation 31.18 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 2 Day 1 | 91.33 percent occupancy | Standard Deviation 9.38 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: SFU | 95.00 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 1 Day 8 | 92.18 percent occupancy | Standard Deviation 13.53 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 1 Day 1 | 97.18 percent occupancy | Standard Deviation 12.62 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 1 Day 1 | 5.70 percent occupancy | Standard Deviation 7.96 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 2 Day 1 | 34.83 percent occupancy | Standard Deviation 30.25 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 1 Day 8 | 90.10 percent occupancy | Standard Deviation 15.62 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 1 Day 8 | 67.53 percent occupancy | Standard Deviation 17.54 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 5 Day 8 | 83.35 percent occupancy | Standard Deviation 23.55 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 1 Day 8 | 91.88 percent occupancy | Standard Deviation 19.21 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 5 Day 1 | 106.60 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 1 Day 1 | 90.58 percent occupancy | Standard Deviation 73.61 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 3 Day 1 | 92.90 percent occupancy | Standard Deviation 11.46 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 1 Day 1 | 98.73 percent occupancy | Standard Deviation 12.28 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 9 Day 1 | 105.60 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 2 Day 1 | 96.63 percent occupancy | Standard Deviation 5.83 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 9 Day 1 | 101.20 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Study Completion | 99.90 percent occupancy | Standard Deviation 11.88 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 1 Day 1 | 99.80 percent occupancy | Standard Deviation 11.72 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 1 Day 1 | 0.28 percent occupancy | Standard Deviation 0.55 |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 5 Day 1 | 75.00 percent occupancy | — |
| Part A: Lomvastomig 1200 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 3 Day 1 | 94.50 percent occupancy | Standard Deviation 8.91 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Study Completion | 100.50 percent occupancy | Standard Deviation 0.71 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 3 Day 1 | 96.90 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: SFU | 92.15 percent occupancy | Standard Deviation 2.19 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 9 Day 1 | 89.00 percent occupancy | Standard Deviation 4.67 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 2 Day 1 | 100.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 5 Day 1 | 90.35 percent occupancy | Standard Deviation 2.05 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 1 Day 8 | 91.30 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 1 Day 1 | 94.80 percent occupancy | Standard Deviation 19.83 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 1 Day 8 | 100.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 1 Day 1 | 97.47 percent occupancy | Standard Deviation 10.11 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 2 Day 1 | 95.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 3 Day 1 | 100.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 9 Day 1 | 99.15 percent occupancy | Standard Deviation 5.16 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 5 Day 1 | 91.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 5 Day 1 | 89.15 percent occupancy | Standard Deviation 12.52 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Study Completion | 100.95 percent occupancy | Standard Deviation 1.34 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 5 Day 1 | 108.10 percent occupancy | Standard Deviation 14.42 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 5 Day 1 | 88.50 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 5 Day 1 | 79.10 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 5 Day 8 | 106.05 percent occupancy | Standard Deviation 10.25 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 9 Day 1 | 107.90 percent occupancy | Standard Deviation 9.33 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 5 Day 1 | 95.65 percent occupancy | Standard Deviation 6.15 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: SFU | 88.75 percent occupancy | Standard Deviation 2.19 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 1 Day 1 | 102.67 percent occupancy | Standard Deviation 12.71 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 1 Day 1 | 73.55 percent occupancy | Standard Deviation 27.93 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 3 Day 1 | 100.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Study Completion | 101.25 percent occupancy | Standard Deviation 1.2 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 2 Day 1 | 102.00 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 1 Day 1 | 117.73 percent occupancy | Standard Deviation 38.13 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 1 Day 8 | 101.90 percent occupancy | Standard Deviation 39.74 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 5 Day 8 | 100.50 percent occupancy | Standard Deviation 3.96 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 2 Day 1 | 112.15 percent occupancy | Standard Deviation 35.85 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 3 Day 1 | 71.83 percent occupancy | Standard Deviation 18.61 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 5 Day 8 | 106.90 percent occupancy | Standard Deviation 12.3 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 5 Day 1 | 82.20 percent occupancy | — |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 9 Day 1 | 101.40 percent occupancy | Standard Deviation 0 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: SFU | 90.25 percent occupancy | Standard Deviation 2.05 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+:Predose on Cycle 5 Day 1 | 94.90 percent occupancy | Standard Deviation 8.77 |
| Part A: Lomvastomig 1800 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 1 Day 8 | 88.40 percent occupancy | — |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 2 Day 1 | 98.85 percent occupancy | Standard Deviation 16.69 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 1 Day 1 | 88.31 percent occupancy | Standard Deviation 43.57 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: SFU | 98.30 percent occupancy | Standard Deviation 5.23 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Study Completion | 93.83 percent occupancy | Standard Deviation 10.53 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 2 Day 1 | 100.77 percent occupancy | Standard Deviation 12.11 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 9 Day 1 | 113.55 percent occupancy | Standard Deviation 20 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 2 Day 1 | 101.78 percent occupancy | Standard Deviation 20.05 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 1 Day 8 | 105.34 percent occupancy | Standard Deviation 23.71 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 1 Day 1 | 16.37 percent occupancy | Standard Deviation 20.93 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 1 Day 1 | 103.07 percent occupancy | Standard Deviation 27.26 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 1 Day 1 | 96.63 percent occupancy | Standard Deviation 25.26 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 1 Day 1 | 95.69 percent occupancy | Standard Deviation 24.36 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+:Predose on Cycle 5 Day 1 | 92.72 percent occupancy | Standard Deviation 48.52 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 1 Day 8 | 106.75 percent occupancy | Standard Deviation 64.75 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 9 Day 1 | 109.45 percent occupancy | Standard Deviation 12.18 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 1 Day 1 | 99.85 percent occupancy | Standard Deviation 25.09 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 5 Day 1 | 107.54 percent occupancy | Standard Deviation 26.49 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 1 Day 8 | 102.53 percent occupancy | Standard Deviation 20.01 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Postdose on Cycle 5 Day 8 | 107.59 percent occupancy | Standard Deviation 31.13 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 1 Day 1 | 17.60 percent occupancy | Standard Deviation 25.08 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Study Completion | 96.73 percent occupancy | Standard Deviation 9.11 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 3 Day 1 | 115.75 percent occupancy | Standard Deviation 57.23 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: EOI on Cycle 5 Day 1 | 94.86 percent occupancy | Standard Deviation 20.02 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 1 Day 8 | 103.77 percent occupancy | Standard Deviation 28.34 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Postdose on Cycle 5 Day 8 | 103.67 percent occupancy | Standard Deviation 9.4 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: EOI on Cycle 5 Day 1 | 93.90 percent occupancy | Standard Deviation 15.31 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 5 Day 1 | 112.00 percent occupancy | Standard Deviation 17.78 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:EOI on Cycle 5 Day 1 | 100.64 percent occupancy | Standard Deviation 11.65 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD56+/16+:Predose on Cycle 9 Day 1 | 98.86 percent occupancy | Standard Deviation 18.06 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 9 Day 1 | 109.20 percent occupancy | Standard Deviation 23.66 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: SFU | 98.35 percent occupancy | Standard Deviation 2.33 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Study Completion | 97.98 percent occupancy | Standard Deviation 10.69 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Postdose on Cycle 5 Day 1 | 102.90 percent occupancy | Standard Deviation 16.18 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Postdose on Cycle 5 Day 8 | 108.28 percent occupancy | Standard Deviation 15.34 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD4+: Predose on Cycle 3 Day 1 | 98.44 percent occupancy | Standard Deviation 33.59 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: EOI on Cycle 5 Day 1 | 95.77 percent occupancy | Standard Deviation 12.49 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 5 Day 1 | 111.22 percent occupancy | Standard Deviation 23.82 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 3 Day 1 | 105.48 percent occupancy | Standard Deviation 25.17 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: SFU | 100.75 percent occupancy | Standard Deviation 1.06 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 2 Day 1 | 100.30 percent occupancy | Standard Deviation 12.1 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD8+: Predose on Cycle 3 Day 1 | 95.82 percent occupancy | Standard Deviation 35.78 |
| Part A: Lomvastomig 2100 mg | Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay | CD3+: Predose on Cycle 1 Day 1 | 14.37 percent occupancy | Standard Deviation 21.43 |
Secondary
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies
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).
Time frame: At screening and Cycle 3 Day 1
Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed = participants with data available for analysis. Number analyzed=number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 2 | 912.58 cells per millimetre square (cells/mm^2) | Standard Deviation 1089.9 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 1 | 1090.51 cells per millimetre square (cells/mm^2) | Standard Deviation 1001.71 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Archival Metastasis Samples | 215.16 cells per millimetre square (cells/mm^2) | Standard Deviation 319.52 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Archival Primary Samples | 374.92 cells per millimetre square (cells/mm^2) | Standard Deviation 530.17 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 1 | 765.44 cells per millimetre square (cells/mm^2) | Standard Deviation 986.47 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Archival Metastasis Samples | 29.51 cells per millimetre square (cells/mm^2) | — |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Archival Primary Samples | 764.26 cells per millimetre square (cells/mm^2) | Standard Deviation 470.25 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 2 | 790.76 cells per millimetre square (cells/mm^2) | Standard Deviation 462.38 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 2 | 288.21 cells per millimetre square (cells/mm^2) | — |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 1 | 221.87 cells per millimetre square (cells/mm^2) | Standard Deviation 363.76 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 1 | 510.21 cells per millimetre square (cells/mm^2) | Standard Deviation 601.1 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Archival Primary Samples | 275.02 cells per millimetre square (cells/mm^2) | Standard Deviation 347.75 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies | Fresh Sample 2 | 322.23 cells per millimetre square (cells/mm^2) | Standard Deviation 256.74 |
Secondary
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood
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.
Time frame: 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)
Population: The safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 1 | 12.45 cells per microliter (cells/µL) | Standard Deviation 8.64 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 2 | 445.53 cells per microliter (cells/µL) | Standard Deviation 228.03 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 9 Day 1 | 14.27 cells per microliter (cells/µL) | Standard Deviation 12.58 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Study Completion | 296.70 cells per microliter (cells/µL) | Standard Deviation 177.13 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 8 | 516.80 cells per microliter (cells/µL) | Standard Deviation 332.31 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 8 | 15.33 cells per microliter (cells/µL) | Standard Deviation 9.98 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: SFU | 429.38 cells per microliter (cells/µL) | Standard Deviation 302.79 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 9 Day 1 | 503.91 cells per microliter (cells/µL) | Standard Deviation 425.19 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 8 | 364.09 cells per microliter (cells/µL) | Standard Deviation 264.35 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 1 | 350.63 cells per microliter (cells/µL) | Standard Deviation 186.81 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 2 | 19.63 cells per microliter (cells/µL) | Standard Deviation 26.26 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 1 | 16.27 cells per microliter (cells/µL) | Standard Deviation 12.27 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 2 Day 1 | 378.54 cells per microliter (cells/µL) | Standard Deviation 250.58 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: SFU | 15.63 cells per microliter (cells/µL) | Standard Deviation 12.93 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 3 Day 1 | 16.10 cells per microliter (cells/µL) | Standard Deviation 23.21 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 2 Day 1 | 18.12 cells per microliter (cells/µL) | Standard Deviation 22.33 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 3 Day 1 | 422.00 cells per microliter (cells/µL) | Standard Deviation 380.62 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 2 | 371.61 cells per microliter (cells/µL) | Standard Deviation 219.58 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 8 | 14.34 cells per microliter (cells/µL) | Standard Deviation 11.67 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 2 | 13.94 cells per microliter (cells/µL) | Standard Deviation 16.29 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 1 | 403.88 cells per microliter (cells/µL) | Standard Deviation 270.34 |
| Part A: Lomvastomig 70 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Study Completion | 10.58 cells per microliter (cells/µL) | Standard Deviation 7.8 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 8 | 342.59 cells per microliter (cells/µL) | Standard Deviation 223.74 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 1 | 293.25 cells per microliter (cells/µL) | Standard Deviation 137.62 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 2 | 317.28 cells per microliter (cells/µL) | Standard Deviation 175.47 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 2 Day 1 | 298.91 cells per microliter (cells/µL) | Standard Deviation 153.88 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 3 Day 1 | 310.47 cells per microliter (cells/µL) | Standard Deviation 171.87 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 1 | 269.00 cells per microliter (cells/µL) | Standard Deviation 106.32 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 2 | 285.71 cells per microliter (cells/µL) | Standard Deviation 120.35 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 8 | 267.57 cells per microliter (cells/µL) | Standard Deviation 116.42 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: SFU | 453.00 cells per microliter (cells/µL) | Standard Deviation 212.13 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Study Completion | 289.83 cells per microliter (cells/µL) | Standard Deviation 168.98 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 1 | 11.83 cells per microliter (cells/µL) | Standard Deviation 8.67 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 2 | 13.00 cells per microliter (cells/µL) | Standard Deviation 12.76 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 8 | 13.64 cells per microliter (cells/µL) | Standard Deviation 12.62 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 2 Day 1 | 17.52 cells per microliter (cells/µL) | Standard Deviation 23.14 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 3 Day 1 | 13.41 cells per microliter (cells/µL) | Standard Deviation 9.21 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 1 | 6.88 cells per microliter (cells/µL) | Standard Deviation 2.42 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 2 | 7.83 cells per microliter (cells/µL) | Standard Deviation 4.17 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 8 | 7.00 cells per microliter (cells/µL) | Standard Deviation 2.08 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: SFU | 22.50 cells per microliter (cells/µL) | Standard Deviation 14.85 |
| Part A: Lomvastomig 210 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Study Completion | 9.58 cells per microliter (cells/µL) | Standard Deviation 10.49 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 8 | 6.67 cells per microliter (cells/µL) | Standard Deviation 3.79 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 2 | 7.71 cells per microliter (cells/µL) | Standard Deviation 7.45 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: SFU | 7.50 cells per microliter (cells/µL) | Standard Deviation 7.78 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 9 Day 1 | 237.00 cells per microliter (cells/µL) | — |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 8 | 179.00 cells per microliter (cells/µL) | Standard Deviation 68.02 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 2 | 6.75 cells per microliter (cells/µL) | Standard Deviation 2.22 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: SFU | 201.00 cells per microliter (cells/µL) | Standard Deviation 209.3 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 2 | 260.50 cells per microliter (cells/µL) | Standard Deviation 59.52 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Study Completion | 193.80 cells per microliter (cells/µL) | Standard Deviation 136.6 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 5 Day 1 | 234.00 cells per microliter (cells/µL) | Standard Deviation 72.48 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 1 | 252.60 cells per microliter (cells/µL) | Standard Deviation 224.48 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 1 | 7.36 cells per microliter (cells/µL) | Standard Deviation 5.51 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 3 Day 1 | 193.18 cells per microliter (cells/µL) | Standard Deviation 81.24 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 2 | 296.20 cells per microliter (cells/µL) | Standard Deviation 519.44 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 8 | 11.00 cells per microliter (cells/µL) | Standard Deviation 4.88 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 9 Day 1 | 6.00 cells per microliter (cells/µL) | — |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 2 Day 1 | 14.87 cells per microliter (cells/µL) | Standard Deviation 6.62 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 2 Day 1 | 245.93 cells per microliter (cells/µL) | Standard Deviation 226.21 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 3 Day 1 | 13.45 cells per microliter (cells/µL) | Standard Deviation 8.71 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Study Completion | 14.80 cells per microliter (cells/µL) | Standard Deviation 9.31 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 5 Day 1 | 9.00 cells per microliter (cells/µL) | Standard Deviation 1.73 |
| Part A: Lomvastomig 615 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 8 | 292.47 cells per microliter (cells/µL) | Standard Deviation 349.48 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 2 | 8.00 cells per microliter (cells/µL) | Standard Deviation 2.83 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 1 | 256.00 cells per microliter (cells/µL) | Standard Deviation 138.59 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 3 Day 1 | 199.00 cells per microliter (cells/µL) | — |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 3 Day 1 | 8.00 cells per microliter (cells/µL) | — |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 8 | 13.00 cells per microliter (cells/µL) | — |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 2 Day 1 | 257.00 cells per microliter (cells/µL) | Standard Deviation 66.47 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 8 | 329.00 cells per microliter (cells/µL) | — |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+: Cycle 1 Day 2 | 306.50 cells per microliter (cells/µL) | Standard Deviation 111.02 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 2 Day 1 | 8.50 cells per microliter (cells/µL) | Standard Deviation 0.71 |
| Part A: Lomvastomig 1200 mg | Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood | CD3+CD8+Ki67+: Cycle 1 Day 1 | 5.50 cells per microliter (cells/µL) | Standard Deviation 2.12 |
Secondary
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0
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, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.
Time frame: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months)
Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | AEs (Any Grade) | 34 Participants |
| Part A: Lomvastomig 70 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 1 AE | 7 Participants |
| Part A: Lomvastomig 70 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 2 AE | 15 Participants |
| Part A: Lomvastomig 70 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 3 AE | 11 Participants |
| Part A: Lomvastomig 70 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 4 AE | 1 Participants |
| Part A: Lomvastomig 70 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 5 AE | 0 Participants |
| Part A: Lomvastomig 210 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 5 AE | 1 Participants |
| Part A: Lomvastomig 210 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 3 AE | 9 Participants |
| Part A: Lomvastomig 210 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | AEs (Any Grade) | 25 Participants |
| Part A: Lomvastomig 210 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 2 AE | 10 Participants |
| Part A: Lomvastomig 210 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 1 AE | 5 Participants |
| Part A: Lomvastomig 210 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 615 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 1 AE | 2 Participants |
| Part A: Lomvastomig 615 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 2 AE | 5 Participants |
| Part A: Lomvastomig 615 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 3 AE | 8 Participants |
| Part A: Lomvastomig 615 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 5 AE | 0 Participants |
| Part A: Lomvastomig 615 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 4 AE | 0 Participants |
| Part A: Lomvastomig 615 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | AEs (Any Grade) | 15 Participants |
| Part A: Lomvastomig 1200 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 4 AE | 1 Participants |
| Part A: Lomvastomig 1200 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 5 AE | 1 Participants |
| Part A: Lomvastomig 1200 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 1 AE | 0 Participants |
| Part A: Lomvastomig 1200 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 3 AE | 10 Participants |
| Part A: Lomvastomig 1200 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | AEs (Any Grade) | 16 Participants |
| Part A: Lomvastomig 1200 mg | Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 | Grade 2 AE | 4 Participants |
Secondary
Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig
Time frame: 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)
Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 140 day*µg/mL | Geometric Coefficient of Variation 37.8 |
| Part A: Lomvastomig 70 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 105 day*µg/mL | — |
| Part A: Lomvastomig 210 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 427 day*µg/mL | Geometric Coefficient of Variation 15.9 |
| Part A: Lomvastomig 210 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 1190 day*µg/mL | Geometric Coefficient of Variation 7.7 |
| Part A: Lomvastomig 615 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 932 day*µg/mL | Geometric Coefficient of Variation 29 |
| Part A: Lomvastomig 615 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 1110 day*µg/mL | Geometric Coefficient of Variation 74.2 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 2600 day*µg/mL | Geometric Coefficient of Variation 17.4 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 5440 day*µg/mL | Geometric Coefficient of Variation 17.6 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 6260 day*µg/mL | Geometric Coefficient of Variation 21.3 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 3120 day*µg/mL | Geometric Coefficient of Variation 26.6 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 3180 day*µg/mL | Geometric Coefficient of Variation 17.3 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 12300 day*µg/mL | — |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 11700 day*µg/mL | Geometric Coefficient of Variation 1.3 |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 3680 day*µg/mL | Geometric Coefficient of Variation 26.9 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 5060 day*µg/mL | Geometric Coefficient of Variation 20 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 13700 day*µg/mL | Geometric Coefficient of Variation 26.4 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 4730 day*µg/mL | Geometric Coefficient of Variation 24 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 11200 day*µg/mL | Geometric Coefficient of Variation 41.1 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 4550 day*µg/mL | Geometric Coefficient of Variation 29.6 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 11200 day*µg/mL | Geometric Coefficient of Variation 36.1 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 9650 day*µg/mL | Geometric Coefficient of Variation 41.5 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 4590 day*µg/mL | Geometric Coefficient of Variation 20.2 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 5 | 11100 day*µg/mL | Geometric Coefficient of Variation 33.6 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig | Cycle 1 | 5150 day*µg/mL | Geometric Coefficient of Variation 25.4 |
Secondary
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig
For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.
Time frame: 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)
Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 140 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 37.8 |
| Part A: Lomvastomig 70 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 114 day*micrograms/milliliters (day*µg/mL) | — |
| Part A: Lomvastomig 210 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 426 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 16 |
| Part A: Lomvastomig 210 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 1200 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 8 |
| Part A: Lomvastomig 615 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 927 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 28.8 |
| Part A: Lomvastomig 615 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 1120 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 73.6 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 2540 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 22.1 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 5470 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 17.3 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 6620 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 13.6 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 3040 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 31.6 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 2700 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 52 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 12200 day*micrograms/milliliters (day*µg/mL) | — |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 13800 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 28 |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 3700 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 26.8 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 4880 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 30 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 14200 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 28.4 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 4700 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 27.9 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 11500 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 43.5 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 4600 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 27.3 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 11700 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 38.1 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 9910 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 39.5 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 4720 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 25.7 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 5 | 11700 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 28.7 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig | Cycle 1 | 5200 day*micrograms/milliliters (day*µg/mL) | Geometric Coefficient of Variation 24.4 |
Secondary
Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig
For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.
Time frame: 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)
Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 5.52 µg/mL | Geometric Coefficient of Variation 23.6 |
| Part A: Lomvastomig 70 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 2.16 µg/mL | — |
| Part A: Lomvastomig 210 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 62.2 µg/mL | Geometric Coefficient of Variation 14.5 |
| Part A: Lomvastomig 210 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 21.4 µg/mL | Geometric Coefficient of Variation 9.2 |
| Part A: Lomvastomig 615 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 59.7 µg/mL | Geometric Coefficient of Variation 37.4 |
| Part A: Lomvastomig 615 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 40.4 µg/mL | Geometric Coefficient of Variation 43.2 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 116 µg/mL | Geometric Coefficient of Variation 17 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 267 µg/mL | Geometric Coefficient of Variation 8.8 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 415 µg/mL | Geometric Coefficient of Variation 24.6 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 147 µg/mL | Geometric Coefficient of Variation 39.1 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 157 µg/mL | Geometric Coefficient of Variation 43.2 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 661 µg/mL | — |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 157 µg/mL | Geometric Coefficient of Variation 29.4 |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 549 µg/mL | Geometric Coefficient of Variation 22 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 245 µg/mL | Geometric Coefficient of Variation 29.3 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 678 µg/mL | Geometric Coefficient of Variation 32.7 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 520 µg/mL | Geometric Coefficient of Variation 49.6 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 217 µg/mL | Geometric Coefficient of Variation 38.2 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 184 µg/mL | Geometric Coefficient of Variation 54.1 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 495 µg/mL | Geometric Coefficient of Variation 39.2 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 194 µg/mL | Geometric Coefficient of Variation 24.8 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 470 µg/mL | Geometric Coefficient of Variation 59 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 1 | 216 µg/mL | Geometric Coefficient of Variation 46.1 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig | Cycle 5 | 533 µg/mL | Geometric Coefficient of Variation 44.3 |
Secondary
Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig
Time frame: 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)
Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 21.5 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 40 |
| Part A: Lomvastomig 70 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 20.2 micrograms/milliliters (µg/mL) | — |
| Part A: Lomvastomig 210 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 61.7 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 25.2 |
| Part A: Lomvastomig 210 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 128 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 8.3 |
| Part A: Lomvastomig 615 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 148 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 18.5 |
| Part A: Lomvastomig 615 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 116 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 116.9 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 408 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 5.7 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 546 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 14.8 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 781 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 30.8 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 530 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 20.8 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 518 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 8.8 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1600 micrograms/milliliters (µg/mL) | — |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1500 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 0 |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 575 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 29.4 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 740 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 14.4 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1520 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 17.5 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 791 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 43.3 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1420 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 32.6 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 704 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 26.2 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1270 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 33.1 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1240 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 23 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 726 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 16.1 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 5 | 1280 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 25.7 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig | Cycle 1 | 754 micrograms/milliliters (µg/mL) | Geometric Coefficient of Variation 24.5 |
Secondary
Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig
Time frame: 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)
Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.777 microgram/milliliter/milligram(µg/mL/mg) | — |
| Part A: Lomvastomig 70 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.307 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 40 |
| Part A: Lomvastomig 210 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.608 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 8.4 |
| Part A: Lomvastomig 210 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.294 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 25.3 |
| Part A: Lomvastomig 615 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.188 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 117 |
| Part A: Lomvastomig 615 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.24 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 18.5 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.455 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 14.8 |
| Part A: Lomvastomig 1200 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.34 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 5.7 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.295 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 20.9 |
| Part A: Lomvastomig 1800 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.434 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 30.8 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.246 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 8.8 |
| Part A: Lomvastomig 2100 mg | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.762 microgram/milliliter/milligram(µg/mL/mg) | — |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.714 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 0 |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.274 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 29.4 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.352 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 14.3 |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.725 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 17.5 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.675 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 32.6 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.377 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 43.2 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.607 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 33 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.335 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 26.2 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.346 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 16.1 |
| Part B4: SCLC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.592 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 22.9 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 1 | 0.359 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 24.4 |
| Part B5: ESCC Expansion Cohort | Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig | Cycle 5 | 0.609 microgram/milliliter/milligram(µg/mL/mg) | Geometric Coefficient of Variation 25.8 |
Secondary
Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)
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).
Time frame: 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)
Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. The number of participants analyzed for each group indicates the number of participants with an ADA assay result from at least one post-baseline sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 3 Participants |
| Part A: Lomvastomig 210 mg | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 2 Participants |
| Part A: Lomvastomig 615 mg | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 0 Participants |
| Part A: Lomvastomig 1200 mg | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 0 Participants |
| Part A: Lomvastomig 1800 mg | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 1 Participants |
| Part A: Lomvastomig 2100 mg | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 3 Participants |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 5 Participants |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 7 Participants |
| Part B4: SCLC Expansion Cohort | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 1 Participants |
| Part B5: ESCC Expansion Cohort | Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 6 Participants |
Secondary
Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig
For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.
Time frame: 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)
Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part A: Lomvastomig 70 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 16.9 days |
| Part A: Lomvastomig 210 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part A: Lomvastomig 210 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14 days |
| Part A: Lomvastomig 615 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part A: Lomvastomig 615 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14.1 days |
| Part A: Lomvastomig 1200 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14.1 days |
| Part A: Lomvastomig 1200 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part A: Lomvastomig 1800 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part A: Lomvastomig 1800 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 15 days |
| Part A: Lomvastomig 2100 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part A: Lomvastomig 2100 mg | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14 days |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14 days |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14.1 days |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14.5 days |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14.5 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 1 | 14 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig | Cycle 5 | 14.2 days |
Secondary
Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig
Time frame: 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)
Population: Pharmacokinetic (PK) population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Lomvastomig 70 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.09 days |
| Part A: Lomvastomig 70 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.16 days |
| Part A: Lomvastomig 210 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.09 days |
| Part A: Lomvastomig 210 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.17 days |
| Part A: Lomvastomig 615 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.125 days |
| Part A: Lomvastomig 615 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 2.5 days |
| Part A: Lomvastomig 1200 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.17 days |
| Part A: Lomvastomig 1200 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 3.57 days |
| Part A: Lomvastomig 1800 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.17 days |
| Part A: Lomvastomig 1800 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.17 days |
| Part A: Lomvastomig 2100 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.09 days |
| Part A: Lomvastomig 2100 mg | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.17 days |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.21 days |
| Part B1: Metastatic Melanoma Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.175 days |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.18 days |
| Part B2: NSCLC Expansion Cohort 1 | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.215 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.17 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.1 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.1 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.1 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.11 days |
| Part B4: SCLC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.17 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 5 | 0.1 days |
| Part B5: ESCC Expansion Cohort | Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig | Cycle 1 | 0.17 days |