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.
Takafumi Koyama, Kan Yonemori, Jun Sato...
https://pubmed.ncbi.nlm.nih.gov/41979863Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06038578
A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 in Combination with Ramucirumab and Paclitaxel for Gastric Cancer
Led by Toray Industries, Inc · Updated on 2025-08-03
146
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TRK-950 in combination with ramucirumab and paclitaxel (RAM+PTX) to treat participants with gastric or gastro-esophageal junction adenocarcinoma. This randomized, open-label Phase 2 study aims to assess the efficacy, safety, optimal dose, and antibody development of TRK-950 at two dose levels compared to RAM+PTX alone. The main goal is to measure progression-free survival, along with overall survival, response rates, disease control, safety, pharmacokinetics, and immunogenicity. Participants are randomly assigned to one of three groups: one receiving 5 mg/kg TRK-950 with RAM and PTX, another receiving 10 mg/kg TRK-950 with RAM and PTX, and a third group receiving only RAM and PTX. TRK-950 is given intravenously on days 1, 8, 15, and 22 of each 28-day cycle. Ramucirumab is administered intravenously on days 1 and 15, and paclitaxel is given intravenously on days 1, 8, and 15 of each cycle. During the study, participants undergo regular evaluations including scans to measure tumor response, lab tests to check organ function, and monitoring for side effects. Researchers measure progression-free survival, overall survival, response rates, duration of response, disease control rate, antibody development, and quality of life through questionnaires. Safety is closely observed up to 45 days after the last treatment. The study may continue for approximately 24 months, with assessments scheduled throughout this period.
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 unresectable gastric or gastro-esophageal junction adenocarcinoma
- Eligible to receive ramucirumab plus paclitaxel treatment
- Documented disease progression during or after prior treatment according to specified criteria
- Presence of measurable 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 (19 years or older in Korea)
- Signed, written informed consent
- Adequate organ function based on recent lab tests
- Use of effective contraception during the study and for 6 months after last dose if of child-producing potential
- Tumor tissue evaluable for CAPRIN-1 staining meeting expression level requirements
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
- Prolonged corrected QT interval beyond specified limits
- Symptomatic congestive heart failure or poorly controlled arrhythmia
- Recent arterial thrombotic events within 3 months
- History or current pneumonitis requiring steroids
- Symptomatic venous thromboembolism or current anticoagulant treatment (except low-dose prophylaxis)
- Uncontrolled hypertension despite treatment
- Active, uncontrolled infections requiring systemic therapy
- Pregnant or nursing women
- Recent radiation, chemotherapy, immunotherapy, targeted or investigational therapy within specified timeframes
- Significant bleeding disorders or recent gastrointestinal bleeding
- Clinically significant ascites or recent paracentesis
- History of gastrointestinal perforation or fistula within 6 months
- Serious or non-healing wounds, peptic ulcers, or bone fractures within 28 days
- Bowel obstruction, inflammatory bowel diseases, or extensive intestinal resection with chronic diarrhea
- Known active HIV, hepatitis B or C infection (with exceptions for controlled cases)
- Concurrent enrollment in incompatible clinical trials or recent investigational drug use
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive intravenous infusions of TRK-950 at one of two dose levels in combination with Ramucirumab and Paclitaxel on specified days in 28-day cycles.
Multiple visits per cycle: TRK-950 on Days 1, 8, 15, and 21; Ramucirumab on Days 1 and 15; Paclitaxel on Days 1, 8, and 15
Follow-up
Duration - Up to approximately 24 months
Participants are monitored for safety and survival outcomes up to approximately 24 months after randomization.
Periodic visits for assessments up to 24 months
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
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Research Team
(
(Asia sites)Toray Contact for Clinical Trial Information
(
(US sites) Contact for Clinical Trial Information
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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