NCT05423262

A Study of TRK-950 in Patients With Advanced Solid Tumors

A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Part 1 • To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors Part 2 • To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy Part 3 • To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists

Detailed description

This is an open-label phase I/II study and consists of three parts. In Part 1, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists will receive two dose level of TRK-950. In Part 2, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals will receive two dose level of TRK-950 in combination with Nivolumab. In Part 3, patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists will receive one dose level of TRK-950. The objectives of this study are to determine the safety, tolerability, pharmacokinetic (PK) profile and the incidence of the development of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against TRK-950.

Conditions

• Solid Tumor
• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	TRK-950	5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
BIOLOGICAL	TRK-950	10 mg/kg administered intravenously over 60 minutes (weekly)
BIOLOGICAL	TRK-950	20 mg/kg administered intravenously over 60 minutes (bi-weekly)
DRUG	Nivolumab	240 mg administered intravenously over 30 minutes (bi-weekly)
BIOLOGICAL	TRK-950	10 mg/kg administered Intravenously over 60 minutes (weekly)

Timeline

• Start date: 2022-07-06
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-06-21
• Last updated: 2026-04-13

Locations

10 sites across 1 country: Japan