A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
NCT ID: NCT06038578
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
146 participants
INTERVENTIONAL
2023-10-04
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel
Participants who will be randomized to receive a 5 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m\^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
TRK-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
Ramucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
Paclitaxel
80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel
Participants who will be randomized to receive a 10 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m\^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
TRK-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
Ramucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
Paclitaxel
80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Arm C: Ramucirumab+Paclitaxel
Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m\^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
Ramucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
Paclitaxel
80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Interventions
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TRK-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
Ramucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
Paclitaxel
80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient is eligible to receive Ramucirumab + Paclitaxel.
* Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and/or cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:
1. First treatment for metastatic disease or locally advanced disease without experiencing adjuvant / neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment
2. Adjuvant / neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment
3. Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment
4. Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment
* Presence of primary or metastatic disease, measurable 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 in the US and Japan, and ≥ 19 years of age in Korea.
* Signed, written IRB-approved informed consent.
* Adequate organ function from specimens collected within 14 days prior to Day 1.
* For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.
* All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.
Exclusion Criteria
* HER2 positive gastric or GEJ adenocarcinoma.
* Major surgery within 28 days prior to randomization.
* Baseline corrected QT (QTc) interval of \> 470 msec for females and \> 450 msec for males calculated using Fridericia's formula.
* New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.
* The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.
* The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
* Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)
* Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Pregnant or nursing women.
* Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).
* The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.
* Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.
* History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
* The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
* The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
* Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.
* The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.
18 Years
ALL
No
Sponsors
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Toray Industries, Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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(Asia sites)Toray Contact for Clinical Trial Information
Role: CONTACT
Facility Contacts
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MD
Role: primary
MD
Role: primary
Role: primary
Clinical Research Coordinator II
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Prinicipal Investigator
Role: primary
Study Coordinator
Role: backup
Principal Investigator
Role: primary
Site Coordinator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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950GCV01
Identifier Type: -
Identifier Source: org_study_id
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