RecruitingPhase 2NCT06038578

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

A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer

Sponsor

Toray Industries, Inc

Enrollment

146 participants

Start Date

Oct 4, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TRK-950 when added to the standard second-line treatment (ramucirumab and paclitaxel) for patients with stomach cancer that has spread or cannot be removed by surgery. **You may be eligible if...** - You have confirmed metastatic or locally advanced stomach or esophageal-stomach junction cancer - Your cancer progressed during or after a previous treatment - You are eligible to receive the standard treatment (ramucirumab + paclitaxel) - You are in generally good health and your organ function is within acceptable limits **You may NOT be eligible if...** - You have not previously received treatment for your cancer - You have serious heart, liver, or kidney disease - You are pregnant or breastfeeding - You are currently enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTRK-950

5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle

DRUGRamucirumab

8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle

DRUGPaclitaxel

80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

Locations(27)

City of Hope

Duarte, California, United States

City of Hope at Orange County Lennar Foundation Cancer Center

Irvine, California, United States

University of California, Los Angeles

Santa Monica, California, United States

Texas Oncology Arlington North

Arlington, Texas, United States

Texas Oncology Bedford

Bedford, Texas, United States

Texas Oncology Dallas Methodist

Dallas, Texas, United States

Texas Oncology Dallas Medical City

Dallas, Texas, United States

Texas Oncology Dallas Presbyterian

Dallas, Texas, United States

Texas Oncology Methodist Charlton Cancer Center

Dallas, Texas, United States

Texas Oncology-Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology Fort Worth Cancer Center

Fort Worth, Texas, United States

Texas Oncology Grapevine

Grapevine, Texas, United States

Texas Oncology Plano East

Plano, Texas, United States

Texas Oncology Plano West

Plano, Texas, United States

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Saitama Prefectural Hospital Organization Saitama Cancer Center

Shinden, Saitama, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

National Cancer Center Hospital

Chūōku, Japan

Osaka International Cancer Institute

Chūōku, Japan

National Cancer Center Hospital East

Kashiwa, Japan

The Cancer Institute Hospital of JFCR

Kōtoku, Japan

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Severance Hospital

Seoul, South Korea

ASAN Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06038578

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