NCT02990481

A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1. Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively. In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.

Conditions

• Locally Advanced or Metastatic Solid Carcinomas
• Colon Cancer
• Cholangiocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-06
• Primary completion: 2019-09-16
• Completion: 2019-09-16
• First posted: 2016-12-13
• Last updated: 2025-04-16

Locations

3 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study