Who may be eligible for this gastric cancer clinical trial?

Adults 18 years and older with metastatic or locally advanced gastric or gastro-esophageal junction adenocarcinoma who are eligible for treatment with ramucirumab and paclitaxel may qualify. Participants should not have received prior treatment with ramucirumab or paclitaxel and must have adequate organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this gastric cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06038578

Phase 2 Study of TRK-950 Combined With Ramucirumab and Paclitaxel for Treating Gastric and Gastroesophageal Junction Adenocarcinoma

Q: What is TRK-950 studying for gastric cancer?

TRK-950 is being studied in combination with ramucirumab and paclitaxel to evaluate its impact on progression-free survival in people with gastric or gastro-esophageal junction adenocarcinoma. The research aims to understand the best dose, safety, and immune response to TRK-950. This study is sponsored by Toray Industries, Inc.

Led by Toray Industries, Inc · Updated on 2026-06-23

146

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of TRK-950 combined with ramucirumab and paclitaxel compared to ramucirumab plus paclitaxel alone in people with gastric or gastro-esophageal junction adenocarcinoma. This phase 2 study aims to assess the effectiveness, safety, best dose, and the development of anti-drug and neutralizing antibodies related to TRK-950. The main goal is to measure progression-free survival, with additional goals including overall survival, response rates, and safety. Participants are randomly assigned to one of three groups one receiving 5 mgkg of TRK-950 with ramucirumab and paclitaxel, another receiving 10 mgkg of TRK-950 with the same combination, and a control group receiving ramucirumab and paclitaxel alone. Treatments are given intravenously on specified days in 28-day cycles, with TRK-950 administered on days 1, 8, 15, and 22, ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. During the study, participants will have various assessments including imaging scans, blood tests for drug levels and antibodies, evaluations of side effects, physical exams, and quality of life questionnaires. Progression-free survival is tracked up to about 24 months, and safety is monitored up to 45 days after the last study dose. The study includes regular treatment cycles and follow-up evaluations to monitor the disease and response to treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed metastatic or locally advanced and unresectable gastric or gastro-esophageal junction adenocarcinoma
Eligible to receive ramucirumab and paclitaxel
Documented disease progression during or after prior treatment according to specified treatment history
Presence of measurable primary or metastatic disease per RECIST v1.1 on CT scan
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 3 months
Age 18 years or older in the US and Japan; 19 years or older in Korea
Signed, IRB-approved informed consent
Adequate organ function from tests within 14 days prior to Day 1
Use of effective contraception during the study and for 6 months after last dose for men and women of child-producing potential
Tumor tissue evaluable for CAPRIN-1 staining meeting cutoff values as defined

You will not qualify if you...

Prior treatment with ramucirumab or paclitaxel
HER2 positive gastric or gastro-esophageal junction adenocarcinoma
Major surgery within 28 days before randomization
Baseline corrected QT interval >470 msec for females and >450 msec for males
New York Heart Association Class II to IV symptomatic congestive heart failure or poorly controlled arrhythmia
Arterial thrombotic events within 3 months prior to randomization
History or current pneumonitis requiring steroids
Symptomatic venous thromboembolism or current anticoagulant treatment (except low-dose prophylactic)
Uncontrolled hypertension (≥150 mmHg systolic or ≥90 mmHg diastolic)
Active, uncontrolled infections requiring systemic therapy
Pregnant or nursing women
Recent radiation therapy within 2 weeks or systemic cancer treatments within 4 weeks prior to randomization
Significant bleeding disorders or recent gastrointestinal bleeding
Clinically significant ascites or regular paracentesis
History of gastrointestinal perforation or fistulae within 6 months
Serious or non-healing wounds, peptic ulcers, or bone fractures within 28 days
Bowel obstruction, inflammatory bowel diseases, or chronic diarrhea
Known active HIV, hepatitis B or C infection (unless viral loads undetectable)
Current enrollment in incompatible clinical trials or recent investigational drug use within 28 days

Research Team

(

(Asia sites)Toray Contact for Clinical Trial Information

(

(US sites) Contact for Clinical Trial Information

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 2 Study of TRK-950 Combined With Ramucirumab and Paclitaxel for Treating Gastric and Gastroesophageal Junction Adenocarcinoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria