tusamitamab ravtansine (sar408701) in combination with ramucirumab in pretreated participants with gastric cancer

Conditions: Adenocarcinoma Gastric; Gastrooesophageal Cancer

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 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

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:
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.