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Sponsor: Sanofi
Conditions: Adenocarcinoma Gastric, Gastrooesophageal Cancer
Interventions: Ramucirumab (CYRAMZA®), Tusamitamab ravtansine (SAR408701)
Countries: Belgium, Japan, Russia, South Korea, Spain, Turkey (Türkiye)
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
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Brussels, Belgium
- Edegem, Belgium
- Leuven, Belgium
- Kashiwa-shi, Chiba, Japan
- Matsuyama, Ehime, Japan
- Sapporo, Hokkaido, Japan
- Sunto-gun, Shizuoka, Japan
- Pushkin, Saint- Petersburg, Sankt-Peterburg, Russia
- Arkhangelsk, Russia
- Seoul, Seoul-teukbyeolsi, South Korea
- Seoul, Seoul-teukbyeolsi, South Korea
- Seoul, Seoul-teukbyeolsi, South Korea
- Seoul, Seoul-teukbyeolsi, South Korea
- Barcelona, Barcelona [Barcelona], Spain
- Barcelona, Barcelona [Barcelona], Spain
- Granada, Spain
- Madrid, Spain
- Ankara, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
- Malatya, Turkey (Türkiye)