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New biologic TRK-950 joins forces with standard chemo to fight stomach cancer

NCT ID NCT06038578

Disease control Sponsor: Toray Industries, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding an experimental biologic called TRK-950 to the standard combination of ramucirumab and paclitaxel helps people with advanced stomach or gastroesophageal junction cancer. Participants receive either the standard two-drug regimen or the standard regimen plus TRK-950 at one of two dose levels. The study measures how long the cancer stays under control, overall survival, and tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRK-950 (a biologic) plus ramucirumab and paclitaxel
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced gastric cancer that has worsened after prior therapy.
What could go wrong
This is an early-phase trial with a small number of participants. The experimental drug may not improve outcomes and could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 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: * 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.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric adenocarcinoma Gastric cancer Gastroesophageal junction adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASAN Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, Jeollanam-do, 58128, South Korea

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope at Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, 41404, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Chūōku, 541-8567, Japan

  • Saitama Prefectural Hospital Organization Saitama Cancer Center

    RECRUITING

    Shinden, Saitama, 362-0806, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13605, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • Texas Oncology Arlington North

    RECRUITING

    Arlington, Texas, 76012, United States

  • Texas Oncology Bedford

    RECRUITING

    Bedford, Texas, 76022, United States

  • Texas Oncology Dallas Medical City

    RECRUITING

    Dallas, Texas, 75230, United States

  • Texas Oncology Dallas Methodist

    RECRUITING

    Dallas, Texas, 75203, United States

  • Texas Oncology Dallas Presbyterian

    RECRUITING

    Dallas, Texas, 75231, United States

  • Texas Oncology Fort Worth Cancer Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Texas Oncology Grapevine

    RECRUITING

    Grapevine, Texas, 76051, United States

  • Texas Oncology Methodist Charlton Cancer Center

    RECRUITING

    Dallas, Texas, 75237, United States

  • Texas Oncology Plano East

    RECRUITING

    Plano, Texas, 75075, United States

  • Texas Oncology Plano West

    RECRUITING

    Plano, Texas, 75093, United States

  • Texas Oncology-Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtoku, 135-8550, Japan

  • University of California, Los Angeles

    RECRUITING

    Santa Monica, California, 90404, United States

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