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

NCT ID: NCT05071053

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2024-11-05

Brief 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 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

Detailed Description

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).

Conditions

Adenocarcinoma Gastric; Gastrooesophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tusamitamab ravtansine+Ramucirumab

Participants received ramucirumab 8 milligram/kilogram (mg/kg) via intravenous (IV) infusion followed by tusamitamab ravtansine loading dose at 170 mg/meter square (m\^2) via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m\^2 via IV infusion at Cycle 2 and every 2 weeks (Q2W) in all subsequent cycles until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Group Type: EXPERIMENTAL

Ramucirumab (CYRAMZA®)

Intervention Type: DRUG

Pharmaceutical Form: Concentrate for solution for infusion

Route of Administration: Intravenous Infusion

Tusamitamab ravtansine (SAR408701)

Intervention Type: DRUG

Pharmaceutical Form: Concentrate for solution for infusion

Route of Administration: Intravenous Infusion

Interventions

Ramucirumab (CYRAMZA®)

Pharmaceutical Form: Concentrate for solution for infusion

Route of Administration: Intravenous Infusion

Intervention Type: DRUG

Tusamitamab ravtansine (SAR408701)

Pharmaceutical Form: Concentrate for solution for infusion

Route of Administration: Intravenous Infusion

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site Number : 0560002

Brussels, , Belgium

Investigational Site Number : 0560003

Edegem, , Belgium

Investigational Site Number : 0560001

Leuven, , Belgium

Investigational Site Number : 3920002

Kashiwa-shi, Chiba, Japan

Investigational Site Number : 3920004

Matsuyama, Ehime, Japan

Investigational Site Number : 3920001

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920003

Sunto-gun, Shizuoka, Japan

Investigational Site Number : 6430003

Pushkin, Saint- Petersburg, Sankt-Peterburg, Russia

Investigational Site Number : 6430001

Arkhangelsk, , Russia

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240002

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240004

Granada, , Spain

Investigational Site Number : 7240001

Madrid, , Spain

Investigational Site Number : 7920003

Ankara, , Turkey (Türkiye)

Investigational Site Number : 7920001

Istanbul, , Turkey (Türkiye)

Investigational Site Number : 7920002

Istanbul, , Turkey (Türkiye)

Investigational Site Number : 7920004

Malatya, , Turkey (Türkiye)

Countries

Belgium; Japan; Russia; South Korea; Spain; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1266-5040

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-001967-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACT16444

Identifier Type: -

Identifier Source: org_study_id