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RECRUITING
NCT05423262
PHASE1/PHASE2

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

Sponsor: Toray Industries, Inc

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2022-07-06

Completion Date

2027-12

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

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)

Locations (9)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan