Actively Recruiting
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
Led by Toray Industries, Inc · Updated on 2025-08-03
146
Participants Needed
27
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or locally advanced unresectable gastric or gastro-esophageal junction adenocarcinoma
- Eligible to receive Ramucirumab plus Paclitaxel treatment
- Documented disease progression during or after treatment as specified by treatment history
- Presence of measurable primary or metastatic disease by CT scan per RECIST v1.1
- 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 or older in Korea
- Signed written informed consent approved by an Institutional Review Board
- Adequate organ function from tests done within 14 days before treatment
- Use of effective contraception during the study and for 6 months after last dose for men and women of child-producing potential
- Pre-screening consent to assess tumor tissue for CAPRIN-1 staining meeting specified cutoff
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
- Corrected QT interval longer than 470 msec (females) or 450 msec (males) using Fridericia's formula
- Symptomatic congestive heart failure or poorly controlled cardiac arrhythmia
- Arterial thrombotic event within 3 months before randomization
- History or current pneumonitis requiring steroids
- Symptomatic venous thromboembolism or current anticoagulant treatment except low-dose prophylaxis
- Uncontrolled high blood pressure despite treatment
- Active uncontrolled infections requiring systemic therapy
- Pregnant or nursing women
- Radiation therapy within 2 weeks or chemotherapy/immunotherapy/targeted/investigational therapy within 4 weeks prior to randomization
- Significant bleeding disorders or gastrointestinal bleeding within 3 months prior
- Clinically significant ascites or recent paracentesis
- History of gastrointestinal perforation or fistula within 6 months prior
- Serious or non-healing wounds, peptic ulcers, or bone fractures within 28 days prior
- Bowel obstruction, inflammatory bowel disease, extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Active infection with HIV, hepatitis B or C; controlled hepatitis allowed
- Concurrent enrollment in incompatible clinical trials or recent investigational drug use within 28 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
University of California, Los Angeles
Santa Monica, California, United States, 90404
Actively Recruiting
4
Texas Oncology Arlington North
Arlington, Texas, United States, 76012
Actively Recruiting
5
Texas Oncology Bedford
Bedford, Texas, United States, 76022
Actively Recruiting
6
Texas Oncology Dallas Methodist
Dallas, Texas, United States, 75203
Actively Recruiting
7
Texas Oncology Dallas Medical City
Dallas, Texas, United States, 75230
Actively Recruiting
8
Texas Oncology Dallas Presbyterian
Dallas, Texas, United States, 75231
Actively Recruiting
9
Texas Oncology Methodist Charlton Cancer Center
Dallas, Texas, United States, 75237
Actively Recruiting
10
Texas Oncology-Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
11
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
12
Texas Oncology Grapevine
Grapevine, Texas, United States, 76051
Actively Recruiting
13
Texas Oncology Plano East
Plano, Texas, United States, 75075
Actively Recruiting
14
Texas Oncology Plano West
Plano, Texas, United States, 75093
Actively Recruiting
15
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
16
Saitama Prefectural Hospital Organization Saitama Cancer Center
Shinden, Saitama, Japan, 362-0806
Actively Recruiting
17
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan, 411-8777
Actively Recruiting
18
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
19
Osaka International Cancer Institute
Chūōku, Japan, 541-8567
Actively Recruiting
20
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
21
The Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Actively Recruiting
22
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13605
Actively Recruiting
23
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Actively Recruiting
24
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
25
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
26
ASAN Medical Center
Seoul, South Korea, 05505
Actively Recruiting
27
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
(
(Asia sites)Toray Contact for Clinical Trial Information
CONTACT
(
(US sites) Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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