drugset / Trial / NCT05071053

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

NCT05071053

Phase 2 Terminated 35 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2021-11-16
Primary completion
2023-06-23
Completion
2024-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramucirumab Monoclonal antibody 8 mg/kg Intravenous
Subject Tusamitamab ravtansine Other / unclassified 100 mg/m2 Intravenous