NCT05071053

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

Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ramucirumab (CYRAMZA®)	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

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-06-23
• Completion: 2024-11-05
• First posted: 2021-10-07
• Last updated: 2025-08-22
• Results posted: 2024-12-05

Locations

21 sites across 6 countries: Belgium, Japan, Russia, South Korea, Spain, Turkey (Türkiye)