Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer

• Status: Recruiting
• Trial end date: 2023-01-03
• Target enrollment: 0
• Participant gender: All

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

• 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Maytansine; Ramucirumab

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.