Trials / Recruiting
RecruitingNCT06038578
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 146 (estimated)
- Sponsor
- Toray Industries, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The primary objective is progression free survival (PFS). Secondary objectives are overall survival, objective response rate, best overall response, duration of response, disease control rate, safety, pharmacokinetics, and immunogenicity of TRK-950 when used in combination with RAM+PTX.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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 |
| DRUG | Ramucirumab | 8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle |
| DRUG | Paclitaxel | 80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle |
Timeline
- Start date
- 2023-10-04
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2023-09-15
- Last updated
- 2025-08-03
Locations
27 sites across 3 countries: United States, Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06038578. Inclusion in this directory is not an endorsement.