Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
Study of Investigational Medication Combination for Advanced Gastric Cancer
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 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
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:
- Conditions: Adenocarcinoma Gastric, Gastrooesophageal Cancer
-
Age: 18 years or above
-
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.
This study investigates the use of an investigational medication in combination with another treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The purpose is to confirm the appropriate dosage and assess the antitumor activity of this combination in patients who have been previously treated.
Participants will receive the investigational medication along with another treatment to observe its effects. The study will also monitor safety, tolerability, and the duration of response. Participants will undergo regular assessments to track progression-free survival, disease control rate, and any immune response. Pharmacokinetics, which is the study of how the drug moves through the body, will also be evaluated.
- Who can participate: Adults with metastatic or locally advanced unresectable gastric or gastroesophageal junction adenocarcinoma and measurable target lesions can participate. High CEACAM5 expression and good performance status are required, and participants must agree to use effective contraception during and after the study.
- Study details: Participants will receive an investigational medication in combination with another treatment. They will be monitored for safety and response to the treatment.
- Study timelines: The study will last 34 weeks.