Adenocarcinoma GastricPhase 2CARMEN-GC01NCT05071053
Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
A Phase 2 study testing Ramucirumab (CYRAMZA®) and Tusamitamab ravtansine (SAR408701) in people with Adenocarcinoma Gastric and Gastrooesophageal Cancer, run by Sanofi at 21 sites in 6 countries.
Trial summary
Primary Objectives: Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma Gastric, Gastrooesophageal Cancer
- What is being tested?
- Ramucirumab (CYRAMZA®) and Tusamitamab ravtansine (SAR408701)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 16 Nov 2021to 5 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma
- Metastatic disease or locally advanced, unresectable disease
- Participants who have measurable target lesion
- Participants with high carcinoembryonic antigen-related cell adhesion molecule (CEACAM5) expression as per central assessment on tumor biospsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of treatment administration
- Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration
- Signed informed consent
Who cannot join
- Untreated brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
- Significant concomitant illness
- History within the last 3 years of an invasive malignancy other than that treated in this study
- Known uncontrolled infection
- Nonresolution of any prior treatment-related toxicity
- Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy
Show all 21Show fewer
- Use of contact lenses
- Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
- History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism
- Major surgery within 28 days prior to Day 1/first IMP infusion; subcutaneous venous access device placement within 7 days prior to Day 1; or postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
- History of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months before the first treatment administration
- Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before the first administration of treatment administration
- Uncontrolled arterial hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg) despite standard medical management.
- Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of treatment administration
- Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of treatment administration
- Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention.
- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
- Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
- Concurrent treatment with any other anticancer therapy
- Prior treatment targeting CEACAM5 or containing maytansinoid DM1 or DM4 or ramucirumab or taxane or targeting VEGF/VEGFR Poor organ function
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
Japan4 sites
Investigational Site Number : 3920002
Kashiwa-shi, Chiba, 277-8577
Investigational Site Number : 3920004
Matsuyama, Ehime, 791-0280
Investigational Site Number : 3920001
Sapporo, Hokkaido, 003-0804
Investigational Site Number : 3920003
Sunto-gun, Shizuoka, 411-8777
South Korea4 sites
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 03722
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 05505
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 135-710
Spain4 sites
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], 08036
Investigational Site Number : 7240004
Granada, 18014
Investigational Site Number : 7240001
Madrid, 28040
Turkey (Türkiye)4 sites
Investigational Site Number : 7920003
Ankara, 06200
Investigational Site Number : 7920001
Istanbul, 34300
Investigational Site Number : 7920002
Istanbul, 34722
Investigational Site Number : 7920004
Malatya
Belgium3 sites
Investigational Site Number : 0560002
Brussels, BE-1200
Investigational Site Number : 0560003
Edegem, 2650
Investigational Site Number : 0560001
Leuven, 3000
Russia2 sites
Investigational Site Number : 6430001
Arkhangelsk, 163045
Investigational Site Number : 6430003
Pushkin, Saint- Petersburg, Sankt-Peterburg, 196603
About this study
Official title: Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors
Primary Objectives:
Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population
Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma
Secondary Objectives:
- To assess safety and tolerability
- To assess durability of response (DOR)
- To assess progression-free survival (PFS)
- To assess the disease control rate (DCR)
- To assess the pharmacokinetics (PK)
- To assess the immunogenicity
Read the detailed description
34 weeks (up to 4 weeks for screening, a median of 18 weeks for treatment, and a median of 12 weeks for end-of-treatment assessments and the safety follow-up visit).
- Conditions
- Adenocarcinoma Gastric, Gastrooesophageal Cancer
- Being tested
- Ramucirumab (CYRAMZA®), Tusamitamab ravtansine (SAR408701)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramucirumab (CYRAMZA®)Drug
Pharmaceutical Form: Concentrate for solution for infusion
Route of Administration: Intravenous Infusion
Tusamitamab ravtansine (SAR408701)Drug
Pharmaceutical Form: Concentrate for solution for infusion
Route of Administration: Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Tusamitamab ravtansine+Ramucirumab | Experimental | 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. Receives: Drug: Ramucirumab (CYRAMZA®); Drug: Tusamitamab ravtansine (SAR408701) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs)
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.
Measured: From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days
Objective Response Rate (ORR)
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.
Measured: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Secondary outcomes (7)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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.
Measured: From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks
Duration of Response (DOR)
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.
Measured: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Progression-free Survival (PFS)
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.
Measured: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Disease Control Rate (DCR)
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.
Measured: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine
Blood samples were collected for the measurement of Ctrough of tusamitamab ravtansine.
Measured: Pre-infusion on Cycle 2 Day 1
Individual Observed Predose Concentrations (Ctrough) of Ramucirumab
Blood samples were collected for the measurement of Ctrough of concentrations of ramucirumab.
Measured: Pre-infusion on Cycle 2 Day 1
Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine
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.
Measured: Upto 92.1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start16 Nov 2021
- Primary completion23 Jun 2023
- Study completion5 Nov 2024
Why it stopped: Sponsor decision, the decision is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma GastricStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071053
- Sponsor's protocol ID
- ACT16444
- Other IDs
- U1111-1266-5040, 2021-001967-26
- Acronym
- CARMEN-GC01
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2021
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors
- ClinicalTrials.gov ID
- NCT05071053
- Acronym / sponsor ID
- CARMEN-GC01 / ACT16444
- Conditions
- Adenocarcinoma Gastric, Gastrooesophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, the decision is not related to any safety concern.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population
Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma
Secondary Objectives:
- To assess safety and tolerability
- To assess durability of response (DOR)
- To assess progression-free survival (PFS)
- To assess the disease control rate (DCR)
- To assess the pharmacokinetics (PK)
- To assess the immunogenicity
Detailed description
34 weeks (up to 4 weeks for screening, a median of 18 weeks for treatment, and a median of 12 weeks for end-of-treatment assessments and the safety follow-up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tusamitamab ravtansine+Ramucirumab | Experimental | Drug: Ramucirumab (CYRAMZA®), Drug: Tusamitamab ravtansine (SAR408701)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma
- Metastatic disease or locally advanced, unresectable disease
- Participants who have measurable target lesion
- Participants with high carcinoembryonic antigen-related cell adhesion molecule (CEACAM5) expression as per central assessment on tumor biospsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (21 listed)
- Untreated brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
- Significant concomitant illness
- History within the last 3 years of an invasive malignancy other than that treated in this study
- Known uncontrolled infection
- Nonresolution of any prior treatment-related toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramucirumab (CYRAMZA®)Pharmaceutical Form: Concentrate for solution for infusion Route of Administration: Intravenous Infusion | Drug | Tusamitamab ravtansine+Ramucirumab |
| Tusamitamab ravtansine (SAR408701)Pharmaceutical Form: Concentrate for solution for infusion Route of Administration: Intravenous Infusion | Drug | Tusamitamab ravtansine+Ramucirumab |
Primary outcome
Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs)
Time frame: 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.
Objective Response Rate (ORR)
Time frame: 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.
7 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks
Duration of Response (DOR)
Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Progression-free Survival (PFS)
Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Disease Control Rate (DCR)
Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks
Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine
Time frame: Pre-infusion on Cycle 2 Day 1
Individual Observed Predose Concentrations (Ctrough) of Ramucirumab
Time frame: Pre-infusion on Cycle 2 Day 1
Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine
Time frame: Upto 92.1 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramucirumab (CYRAMZA®) and Tusamitamab ravtansine (SAR408701) in people with Adenocarcinoma Gastric and Gastrooesophageal Cancer, run by Sanofi at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan, South Korea, Spain, Turkey (Türkiye), Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs) (time frame: From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.