Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (CARMEN-GC01)
Study Overview
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
- To assess durability
- To assess progression-free survival (PFS)
- To assess the disease control rate (DCR)
- To assess the pharmacokinetics (PK)
- To assess the immunogenicity
Study details
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).
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
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Conditions:
Adenocarcinoma Gastric, Gastrooesophageal Cancer
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Age: 18 Years
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Gender: All
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.