Trial · NCT05071053
Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
NCT05071053, Phase 2, Terminated, Sanofi; results first posted 2024-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer. Trials, record NCT05071053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05071053
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
- NCT number
- NCT05071053
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Adenocarcinoma Gastric, Gastrooesophageal Cancer
- Interventions
- Ramucirumab (CYRAMZA®), Tusamitamab ravtansine (SAR408701)
- First posted
- 2021-10-07
- Last updated
- 2025-08-22
- Other registries' IDs
- eudract:2021-001967-26
- Results first posted
- 2024-12-05
- Limitations and caveats
- The study was terminated as per Sponsor decision and not related to any safety concern.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs) | From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days | 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. |
| Primary | Objective Response Rate (ORR) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | 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. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks | 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. |
| Secondary | Duration of Response (DOR) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | 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. |
| Secondary | Progression-free Survival (PFS) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | 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. |
| Secondary | Disease Control Rate (DCR) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | 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. |
| Secondary | Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine | Pre-infusion on Cycle 2 Day 1 | Blood samples were collected for the measurement of Ctrough of tusamitamab ravtansine. |
| Secondary | Individual Observed Predose Concentrations (Ctrough) of Ramucirumab | Pre-infusion on Cycle 2 Day 1 | Blood samples were collected for the measurement of Ctrough of concentrations of ramucirumab. |
| Secondary | Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine | Upto 92.1 weeks | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs) | From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | 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. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | percentage of participants | NUMBER |
| SECONDARY | Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine | Pre-infusion on Cycle 2 Day 1 | 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. | microgram/milliliter (mcg/mL) | MEAN |
| SECONDARY | Individual Observed Predose Concentrations (Ctrough) of Ramucirumab | Pre-infusion on Cycle 2 Day 1 | 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. | mcg/mL | MEAN |
| SECONDARY | Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine | Upto 92.1 weeks | The ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs) | Tusamitamab Ravtansine + Ramucirumab | 0 | Participants | ||
| Objective Response Rate (ORR) | Tusamitamab Ravtansine + Ramucirumab | 14.3 | 95% Confidence Interval 4.81 to 30.26 | percentage of participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Tusamitamab Ravtansine + Ramucirumab | Any TEAE | 35 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Tusamitamab Ravtansine + Ramucirumab | Any TESAE | 15 | Participants | |
| Duration of Response (DOR) | Tusamitamab Ravtansine + Ramucirumab | NA | 95% Confidence Interval 5.520 to NA | months | |
| Progression-free Survival (PFS) | Tusamitamab Ravtansine + Ramucirumab | 3.78 | 95% Confidence Interval 1.511 to 5.749 | months | |
| Disease Control Rate (DCR) | Tusamitamab Ravtansine + Ramucirumab | 62.9 | 95% Confidence Interval 44.92 to 78.53 | percentage of participants | |
| Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine | Tusamitamab Ravtansine + Ramucirumab | 14.7 | Standard Deviation 6.83 | microgram/milliliter (mcg/mL) | |
| Individual Observed Predose Concentrations (Ctrough) of Ramucirumab | Tusamitamab Ravtansine + Ramucirumab | 21.8 | Standard Deviation 10.48 | mcg/mL | |
| Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine | Tusamitamab Ravtansine + Ramucirumab | Treatment-induced ATA | 4 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tusamitamab Ravtansine + Ramucirumab | 35 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine + Ramucirumab | 0 | |
| Overall Study | NOT COMPLETED | Tusamitamab Ravtansine + Ramucirumab | 35 |
Source ClinicalTrials.gov
Adverse events57
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | Tusamitamab Ravtansine + Ramucirumab | 3 | 35 | 3 |
| other | Gastroenteritis | Infections and infestations | Tusamitamab Ravtansine + Ramucirumab | 2 | 35 | 2 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Tusamitamab Ravtansine + Ramucirumab | 2 | 35 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Tusamitamab Ravtansine + Ramucirumab | 6 | 35 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | Tusamitamab Ravtansine + Ramucirumab | 5 | 35 | 12 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tusamitamab Ravtansine + Ramucirumab | 5 | 35 | 11 |
| other | Decreased Appetite | Metabolism and nutrition disorders | Tusamitamab Ravtansine + Ramucirumab | 8 | 35 | 8 |
| other | Dysgeusia | Nervous system disorders | Tusamitamab Ravtansine + Ramucirumab | 3 | 35 | 3 |
| other | Headache | Nervous system disorders | Tusamitamab Ravtansine + Ramucirumab | 3 | 35 | 3 |
| other | Peripheral Sensory Neuropathy | Nervous system disorders | Tusamitamab Ravtansine + Ramucirumab | 3 | 35 | 3 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tusamitamab Ravtansine + Ramucirumab | 13 | 35 |
| Total, other adverse events | Tusamitamab Ravtansine + Ramucirumab | 29 | 35 |
| Total, serious adverse events | Tusamitamab Ravtansine + Ramucirumab | 15 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05071053
GET https://conductscience.org/api/trials/v1/NCT05071053/events?page=2