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

JRCT ID: jRCT2011210035

Registered date:22/09/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Adenocarcinoma gastric, Gastrooesophageal cancer
• Date of first enrollment: 11/11/2021
• Target sample size: 38
• Countries of recruitment: Belgium,Japan,Republic of Korea,Japan,Russian Federation,Japan,Spain,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Drug: Ramucirumab
Pharmaceutical Form: Concentrate for solution for infusion, Route of Administration: Intravenous Infusion
Drug: Tusamitamab ravtansine (SAR408701)
Pharmaceutical Form: Concentrate for solution for infusion, Route of Administration: Intravenous Infusion

Outcome(s)

Primary Outcome

1. Incidence of study drug related dose-limiting toxicities (DLTs)
[ Time Frame: Cycle 1 Day 1 to Cycle 2 Day 14 (approximatively 1 month) ]
Part 1: Number of participants with DLTs

2. Objective Response Rate [ Time Frame: From baseline up to approximately 24 months ]
Part 2: Objective Response Rate (ORR), defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary Outcome

1. Incidence of Adverse Events [ Time Frame: From baseline up to approximately 24 months ]
Number of participants with adverse events

2. Duration of Response [ Time Frame: From baseline up to approximately 24 months ]
Duration of response (DOR), defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first

3. Progression-free survival [ Time Frame: From baseline up to approximately 24 months ]
Progression-free survival, defined as the time from the first investigational medicinal product (IMP) administration to the date of the first documented disease progression or death due to any cause, whichever comes first

4. Disease control rate [ Time Frame: From baseline up to approximately 24 months ]
Disease control rate, defined as the proportion of participants with confirmed CR or PR or SD as BOR per RECIST 1.1

5. Incidence of antitherapeutic antibodies (ATAs) against tusamitamab ravtansine [ Time Frame: From baseline up to approximately 24 months ]
Incidence of antitherapeutic antibodies (ATAs) against tusamitamab ravtansine

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): 2021-001967-26,NCT05071053