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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor, Melanoma

In brief

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

Key facts

Study ID

NCT05423262

Run by

Toray Industries, Inc

People needed

49

Starts

2022-07-06

Expected to finish

2027-12-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Nagoya City University Hospital — Nagoya, Aichi-ken, Japan (enrolling)
• National Hospital Organization Kyushu Cancer Center — Fukuoka, Fukuoka, Japan (enrolling)
• Sapporo Medical University Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Kumamoto University Hospital — Kumamoto, Kumamoto, Japan (enrolling)
• Shinshu University Hospital — Matsumoto, Nagano, Japan (enrolling)
• Niigata Cancer Center Hospital — Niigata, Niigata, Japan (enrolling)
• Saitama Medical University International Medical Center — Hidaka, Saitama, Japan (enrolling)
• Shizuoka Cancer Center — Nagaizumi-chō, Shizuoka, Japan (enrolling)
• National Cancer Center Hospital — Chuo Ku, Tokyo, Japan (enrolling)
• Keio University Hospital — Shinjuku-Ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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