Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Ramucirumab

Maytansine

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Part 1: participants to receive an intravenous (IV) dose of tusamitamab ravtansine in combination with an IV dose of ramucirumab on Day 1 of Cycle 1 followed by an additional IV dose of tusamitamab in combination with IV dose of ramucirumab at Day 1 Cycle 2 of 14-day cycle in all subsequent cycles.

Part 2: participants to receive the recommended dose of tusamitamab ravtansine established in the Part 1 in combination with IV dose of ramucirumab on Day 1 of Cycle 1 followed by IV dose of tusamitamab in combination with IV dose of ramucirumab at Day 1 Cycle 2 of 14-day cycle in all subsequent cycles.

Pharmaceutical Form: Concentrate for solution for infusion

Route of Administration: Intravenous Infusion

Ramucirumab (CYRAMZA®)

Tusamitamab ravtansine (SAR408701)

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
* To assess durability
* To assess progression-free survival (PFS)
* To assess the disease control rate (DCR)
* To assess the pharmacokinetics (PK)
* To assess the immunogenicity

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).

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

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Part 1:

Number of participants with DLTs

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

Number of participants with adverse events

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

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

Disease control rate, defined as the proportion of participants with confirmed CR or PR or SD as BOR per RECIST 1.1

Incidence of antitherapeutic antibodies (ATAs) against tusamitamab ravtansine

Spots Global Cancer Trial Database for ramucirumab (cyramza®)