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

NCT06038578 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 950GCV01
• Study Type: interventional
• Target: 146
• Locations: 3 countries
• Sites: 27

Brief Summary

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

Gastric Adenocarcinoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric Cancer, Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; TRK-950; CAPRIN-1

Outcome Measures

Primary Outcomes (1)

• Progression free Survival (PFS)

  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.

  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

Secondary Outcomes (27)

• Overall survival (OS)

  Time from the date of randomization to the date of death due to any cause, up to approximately 24 months

• Objective response rate (ORR)

  From start of treatment to date of documented disease progression, up to approximately 24 months

• 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

• Objective response rate (ORR)

  From start of treatment to date of documented disease progression, up to approximately 24 months

• Best overall response (BOR)

  From start of treatment to date of documented disease progression, up to approximately 24 months

Study Arms (3)

Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel

EXPERIMENTAL

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.

Biological: TRK-950; Drug: Ramucirumab; Drug: Paclitaxel

Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel

EXPERIMENTAL

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.

Biological: TRK-950; Drug: Ramucirumab; Drug: Paclitaxel

Arm C: Ramucirumab+Paclitaxel

ACTIVE COMPARATOR

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.

Drug: Ramucirumab; Drug: Paclitaxel

Interventions

TRK-950 BIOLOGICAL

5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle

Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel; Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel

Ramucirumab DRUG

8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle

Also known as: CYRAMZA®

Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel; Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel; Arm C: Ramucirumab+Paclitaxel

Paclitaxel DRUG

80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel; Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel; Arm C: Ramucirumab+Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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
• Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (27)

City of Hope

Duarte, California, 91010, United States

RECRUITING

City of Hope at Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

University of California, Los Angeles

Santa Monica, California, 90404, United States

RECRUITING

Texas Oncology Arlington North

Arlington, Texas, 76012, United States

RECRUITING

Texas Oncology Bedford

Bedford, Texas, 76022, United States

RECRUITING

Texas Oncology Dallas Methodist

Dallas, Texas, 75203, United States

RECRUITING

Texas Oncology Dallas Medical City

Dallas, Texas, 75230, United States

RECRUITING

Texas Oncology Dallas Presbyterian

Dallas, Texas, 75231, United States

RECRUITING

Texas Oncology Methodist Charlton Cancer Center

Dallas, Texas, 75237, United States

RECRUITING

Texas Oncology-Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

Texas Oncology Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology Grapevine

Grapevine, Texas, 76051, United States

RECRUITING

Texas Oncology Plano East

Plano, Texas, 75075, United States

RECRUITING

Texas Oncology Plano West

Plano, Texas, 75093, United States

RECRUITING

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Saitama Prefectural Hospital Organization Saitama Cancer Center

Shinden, Saitama, 362-0806, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chūōku, 104-0045, Japan

RECRUITING

Osaka International Cancer Institute

Chūōku, 541-8567, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Kōtoku, 135-8550, Japan

RECRUITING

Seoul National University Bundang Hospital

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

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

ASAN Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Interventions

Ramucirumab; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

(Asia sites)Toray Contact for Clinical Trial Information

CONTACT

+81 467-32-9948; npdd-clinical.toray.mb@mail.toray

(US sites) Contact for Clinical Trial Information

CONTACT

206-818-8621; skahrs@td2inc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 15, 2023
• Study Start: October 4, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); KR (6); JP (7)