Tusamitamab ravtansine (SAR408701) in combination with ramucirumab in pretreated participants with gastric cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 38

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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