RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Toray Industries, Inc • ClinicalTrials.gov ID: NCT05423262

Registry updated: 2026-10-08

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Description

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

Interventions

TRK-950 (Biological)
5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950 (Biological)
10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950 (Biological)
20 mg/kg administered intravenously over 60 minutes (bi-weekly)
Nivolumab (Drug)
240 mg administered intravenously over 30 minutes (bi-weekly)
TRK-950 (Biological)
10 mg/kg administered Intravenously over 60 minutes (weekly)

Eligibility criteria

Inclusion Criteria: * 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. 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. * 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 * Patients with life expectancy of at least 3 months after the start of study drug administration * Patients aged \>=18 years at the time of consent * Patients who are able to provide written consent in person to be a subject of this study * A negative pregnancy test before enrollment (if female of childbearing potential) Exclusion Criteria: * Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy * Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed) * Patients who are unwilling or unable to comply with the protocol specified procedures * Patients who are positive for human immunodeficiency virus (HIV) antibody * Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing * Patients who are positive for hepatitis B surface antigen (HBsAg) * Patients who are positive for HCV RNA

Conditions

Solid Tumor Melanoma

Locations

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
Shizuoka Cancer Center — Nagaizumi-chō, Shizuoka, Japan
National Cancer Center Hospital — Chuo Ku, Tokyo, Japan
Keio University Hospital — Shinjuku-Ku, Tokyo, Japan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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