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A Study of TRK-950 for Gastric Cancer

This study is testing a new treatment called TRK-950 alongside standard medications, ramucirumab and paclitaxel, for people with advanced gastric (stomach) cancer or gastroesophageal junction (where the esophagus meets the stomach) cancer. Researchers want to see if adding TRK-950 improves how long patients live without their cancer growing (progression-free survival). They are also looking at the safety of TRK-950 and how well it works at two different doses. You may be able to join if you have metastatic or locally advanced, unresectable gastric or GEJ adenocarcinoma and are eligible for ramucirumab and paclitaxel treatment. The study aims to enroll 146 participants.

Study design
This interventional study is comparing TRK-950 plus ramucirumab and paclitaxel to ramucirumab and paclitaxel alone. The planned enrollment is 146 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, is measured for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06038578

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Toray Industries, Inc
~146 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:TRK-950RamucirumabPaclitaxel

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free Survival (PFS)
Measured over Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months

Conditions

Gastric Adenocarcinoma
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma

Explore related trials

Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaCaprin-1

NCT06038578

Where you'd take part

This study runs at 27 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope

    Duarte, Californiastudy coordinator listed

    Recruiting

  • City of Hope at Orange County Lennar Foundation Cancer Center

    Irvine, Californiastudy coordinator listed

    Recruiting

  • Texas Oncology Arlington North

    Arlington, Texasstudy coordinator listed

    Recruiting

  • Texas Oncology Bedford

    Bedford, Texasstudy coordinator listed

    Recruiting

  • Texas Oncology Dallas Medical City

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Texas Oncology Dallas Methodist

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Texas Oncology Dallas Presbyterian

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Texas Oncology Fort Worth Cancer Center

    Fort Worth, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

(Asia sites)Toray Contact for Clinical Trial Information
[email protected]
+81 467-32-9948
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.
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:
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

Prior history of treatment with ramucirumab or paclitaxel.
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.

What this trial measures

  • Progression free Survival (PFS)Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months

    Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on Independent Central Review.