A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer

Phase 2 Recruiting 146 enrolled Toray Industries, Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.

Timeline

Start: 2023-10-04
Primary completion: 2026-06-30
Completion: 2026-06-30

Publications

Koyama T, Yonemori K, Sato J, Katsuya Y, Okada M, Yoshida T, Okano F, Yamamoto N. A phase I study of TRK-950, an Anti-CAPRIN-1 antibody, as monotherapy and in combination with nivolumab in Japanese patients with advanced solid tumors. Invest New Drugs. 2026 Apr 14. doi: 10.1007/s10637-026-01609-z. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TRK-950	Monoclonal antibody	5 mg/kg	Intravenous
Subject	TRK-950	Monoclonal antibody	10 mg/kg	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Background	Ramucirumab	Monoclonal antibody	8 mg/kg	Intravenous

A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer

Summary

Timeline

Publications

Drugs

Indications