Trial Outcomes & Findings for Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (NCT NCT05071053)

Last Updated: 2025-08-22

Results Overview

The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: * Grade 4 neutropenia for 7 or more consecutive days. * Grade 3 to 4 neutropenia complicated by fever (temperature \>=38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection. * Grade \>=3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention. * Grade 4 non-hematologic AE. * Grade \>=3 keratopathy. In addition, any other AE that the Investigators and sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days

Results posted on

2025-08-22

Participant Flow

The study was conducted at 23 investigational sites in 6 countries. A total of 45 participants were screened from 16-Nov-2021 to 17-Feb-2023 of which 10 were screen failures due to not meeting eligibility criteria. The study was terminated as per Sponsor decision and not related to any safety concern.

A total of 35 participants were enrolled in this study. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol. Note: Reason for not completed = Reason for permanent full study intervention discontinuation.

Participant milestones

Participant milestones
Measure	Tusamitamab Ravtansine + Ramucirumab Participants received ramucirumab 8 milligram/kilogram (mg/kg) via intravenous (IV) infusion followed by tusamitamab ravtansine loading dose at 170 mg/meter square (m\^2) via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 and every 2 weeks (Q2W) in all subsequent cycles until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Overall Study STARTED	35
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Tusamitamab Ravtansine + Ramucirumab Participants received ramucirumab 8 milligram/kilogram (mg/kg) via intravenous (IV) infusion followed by tusamitamab ravtansine loading dose at 170 mg/meter square (m\^2) via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 and every 2 weeks (Q2W) in all subsequent cycles until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Overall Study Progressive disease	30
Overall Study Adverse Event	5

Baseline Characteristics

Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Age, Continuous	63.1 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days

Population: DLT-evaluable population included all enrolled participants who received 2 cycles with at least 80% of the intended dose for both tusamitamab ravtansine and ramucirumab at each of the 2 first infusions.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=6 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs)	0 Participants

PRIMARY outcome

Timeframe: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Objective Response Rate (ORR)	14.3 percentage of participants Interval 4.81 to 30.26

SECONDARY outcome

Timeframe: From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TEAE	35 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TESAE	15 Participants

SECONDARY outcome

Timeframe: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only participants with confirmed CR or PR as BOR were included in the analysis.

The DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occured first. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=5 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Duration of Response (DOR)	NA months Interval 5.52 to NA indicates that the median and upper limit of confidence interval (CI) were not estimable due to insufficient number of participants with events at study closure.

SECONDARY outcome

Timeframe: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

The PFS was defined as the time from the first study drug administration to the date of the first documented disease progression or death due to any cause, whichever came first as per RECIST v1.1.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Progression-free Survival (PFS)	3.78 months Interval 1.511 to 5.749

SECONDARY outcome

Timeframe: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

The DCR was defined as the percentage of participants who achieved confirmed CR, confirmed PR or stable disease (SD) as per RECIST v1.1. The SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Disease Control Rate (DCR)	62.9 percentage of participants Interval 44.92 to 78.53

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 2 Day 1

Population: The Pharmacokinetic (PK) population included all participants from the all-treated population with at least 1 post-baseline PK concentration (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoint are reported.

Blood samples were collected for the measurement of Ctrough of tusamitamab ravtansine.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=30 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine	14.7 microgram/milliliter (mcg/mL) Standard Deviation 6.83

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 2 Day 1

Population: The PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoint are reported.

Blood samples were collected for the measurement of Ctrough of concentrations of ramucirumab.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=29 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Individual Observed Predose Concentrations (Ctrough) of Ramucirumab	21.8 mcg/mL Standard Deviation 10.48

SECONDARY outcome

Timeframe: Upto 92.1 weeks

Population: The ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive).

Blood samples were collected to assess the presence of ATA against tusamitamab ravtansine in plasma from all participants. ATA incidence was defined as the number of participants found to have seroconverted (treatment-induced ATAs) or boosted their pre-existing ATA response (treatment-boosted ATAs) at any time after first study drug administration.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine + Ramucirumab n=31 Participants Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine Treatment-induced ATA	4 Participants
Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine Treatment-boosted ATA	0 Participants

Adverse Events

Tusamitamab Ravtansine + Ramucirumab

Serious events: 15 serious events

Other events: 29 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 participants at risk Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Infections and infestations Covid-19	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Infections and infestations Pneumonia	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Infections and infestations Pyelonephritis	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Blood and lymphatic system disorders Anaemia	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Metabolism and nutrition disorders Hyponatraemia	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Nervous system disorders Syncope	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Abdominal Pain	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Diarrhoea	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Dysphagia	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Haematochezia	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Intestinal Obstruction	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Nausea	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Vomiting	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Renal and urinary disorders Hydronephrosis	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
General disorders Death	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
General disorders Pyrexia	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Investigations Alanine Aminotransferase Increased	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Investigations Aspartate Aminotransferase Increased	2.9% 1/35 • Number of events 1 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.

Other adverse events

Other adverse events
Measure	Tusamitamab Ravtansine + Ramucirumab n=35 participants at risk Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m\^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
Infections and infestations Covid-19	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Infections and infestations Gastroenteritis	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Infections and infestations Upper Respiratory Tract Infection	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Blood and lymphatic system disorders Anaemia	17.1% 6/35 • Number of events 7 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Blood and lymphatic system disorders Neutropenia	14.3% 5/35 • Number of events 12 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 5/35 • Number of events 11 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Metabolism and nutrition disorders Decreased Appetite	22.9% 8/35 • Number of events 8 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Nervous system disorders Dysgeusia	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Nervous system disorders Headache	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Nervous system disorders Peripheral Sensory Neuropathy	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Eye disorders Keratitis	8.6% 3/35 • Number of events 4 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Eye disorders Keratopathy	22.9% 8/35 • Number of events 13 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Eye disorders Vision Blurred	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Vascular disorders Hypertension	28.6% 10/35 • Number of events 15 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Vascular disorders Hypotension	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Respiratory, thoracic and mediastinal disorders Dysphonia	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Ascites	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Constipation	11.4% 4/35 • Number of events 4 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Diarrhoea	28.6% 10/35 • Number of events 12 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Nausea	20.0% 7/35 • Number of events 8 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Gastrointestinal disorders Vomiting	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Skin and subcutaneous tissue disorders Pruritus	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Musculoskeletal and connective tissue disorders Arthralgia	11.4% 4/35 • Number of events 4 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Musculoskeletal and connective tissue disorders Myalgia	8.6% 3/35 • Number of events 3 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Renal and urinary disorders Proteinuria	14.3% 5/35 • Number of events 9 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
General disorders Asthenia	14.3% 5/35 • Number of events 5 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
General disorders Fatigue	22.9% 8/35 • Number of events 9 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
General disorders Oedema Peripheral	5.7% 2/35 • Number of events 2 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
General disorders Pyrexia	11.4% 4/35 • Number of events 7 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Investigations Alanine Aminotransferase Increased	11.4% 4/35 • Number of events 6 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Investigations Aspartate Aminotransferase Increased	17.1% 6/35 • Number of events 8 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Investigations Neutrophil Count Decreased	8.6% 3/35 • Number of events 8 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.
Investigations Platelet Count Decreased	14.3% 5/35 • Number of events 9 • Adverse events were collected from the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to study termination, approximately 155 weeks. Analysis was performed on all-treated population. All participants received the same dose in this single-group, single arm study as pre-specified in the protocol.

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