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

NCT05071053 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-22

Study results available
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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

Conditions

  • Adenocarcinoma Gastric
  • Gastrooesophageal Cancer

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

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

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05071053 on ClinicalTrials.gov