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

Part of paid clinical trials in Duarte, California.

Sponsor
Toray Industries, Inc
Study ID
NCT06038578
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Ramucirumab — DRUG
    8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
  • Paclitaxel — DRUG
    80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

Study Details

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.

Key Dates

Start date
Oct 4, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Progression free Survival (PFS) [ Time Frame: 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 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
MD
877-467-3411
City of Hope at Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618
MD
877-467-3411
University of California, Los AngelesSanta MonicaCalifornia90404
888-662-8252
Texas Oncology Arlington NorthArlingtonTexas76012
Pre-Screener
[email protected]
Texas Oncology BedfordBedfordTexas76022
Pre-Screener
[email protected]
Texas Oncology Dallas Medical CityDallasTexas75230
Pre-Screener
[email protected]
Texas Oncology Dallas MethodistDallasTexas75203
Pre-Screener
[email protected]
Texas Oncology Dallas PresbyterianDallasTexas75231
Pre-Screener
[email protected]
Texas Oncology Methodist Charlton Cancer CenterDallasTexas75237
Pre-Screener
[email protected]
Texas Oncology-Sammons Cancer CenterDallasTexas75246
Clinical Research Coordinator II
(214)370-1942
Texas Oncology Fort Worth Cancer CenterFort WorthTexas76104
Pre-Screener
[email protected]
Texas Oncology GrapevineGrapevineTexas76051
Pre-Screener
[email protected]
Texas Oncology Plano EastPlanoTexas75075
Pre-Screener
[email protected]
Texas Oncology Plano WestPlanoTexas75093
Pre-Screener
[email protected]

Find similar trials in Duarte, CA

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