Study on TRK-950 with Ramucirumab and Paclitaxel for Treating Gastric Cancer

Sponsor: Toray Industries, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06038578

Provider View

This clinical trial is testing a new treatment that combines TRK-950 with the drugs ramucirumab and paclitaxel to see if it is more effective and safe for patients with gastric or gastro-esophageal junction cancer compared to the standard treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new drug, TRK-950, when used with ramucirumab and paclitaxel in patients with gastric or gastro-esophageal junction cancer. Researchers will compare two different doses of TRK-950 to see which works best and check for any side effects or immune reactions. The main goal is to see how long patients live without the cancer getting worse. Other goals include overall survival, response to treatment, and how long the response lasts.

Description

This study is exploring a new treatment for gastric and gastro-esophageal junction cancer by combining TRK-950 with ramucirumab and paclitaxel. Researchers aim to find out if this combination is more effective than the current standard treatment of ramucirumab and paclitaxel alone. They will test two different doses of TRK-950 to determine the best one. The study will monitor how long patients live without their cancer worsening, overall survival rates, and how well the cancer responds to the treatment. Safety and any immune reactions to TRK-950 will also be closely watched. Participants will need to meet specific health criteria and agree to use contraception during and after the study to prevent pregnancy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic gastric or gastro-esophageal junction cancer that cannot be surgically removed.
  • Eligible to receive ramucirumab and paclitaxel treatment.
  • Cancer must have shown progression during or after previous treatment.
  • Must have measurable cancer as seen on a CT scan.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 3 months.
  • Aged 18 or older in the US and Japan, and 19 or older in Korea.
  • Must provide informed consent to participate.
  • Adequate organ function based on recent tests.
  • Agree to use effective birth control during the study and for 6 months after.
  • Must provide a tumor sample for testing to confirm eligibility.

Exclusion Criteria

  • Previous treatment with ramucirumab or paclitaxel.
  • HER2 positive gastric or gastro-esophageal junction cancer.
  • Major surgery within the last 28 days.
  • Heart rhythm issues or heart failure.
  • Recent heart attack or stroke.
  • History of lung inflammation requiring steroids.
  • Blood clot issues or on blood thinners.
  • Uncontrolled high blood pressure.
  • Active infections needing treatment.
  • Pregnant or breastfeeding women.
  • Recent cancer treatments or radiation.
  • Bleeding disorders or recent significant bleeding.
  • Serious wounds or ulcers.
  • Bowel issues like obstructions or chronic diarrhea.
  • Active HIV, hepatitis B, or C infections.
  • Participation in another clinical trial or recent investigational drug use.

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