A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors
NCT02990481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-04-16
Summary
1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
2. To establish the dose of TRK-950 recommended for future phase 2 studies
Conditions
- Locally Advanced or Metastatic Solid Carcinomas
- Colon Cancer
- Cholangiocarcinoma
Interventions
- BIOLOGICAL
-
TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
- BIOLOGICAL
-
TRK-950
Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
- BIOLOGICAL
-
TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Sponsors & Collaborators
-
Toray Industries, Inc
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-06
- Primary Completion
- 2019-09-16
- Completion
- 2019-09-16
- FDA Drug
- Yes
Countries
- United States
- France
Study Locations
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