Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05423262

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

Led by Toray Industries, Inc · Updated on 2026-04-13

49

Participants Needed

10

Research Sites

282 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older at the time of consent
  • Part 1: Patients with locally advanced or metastatic solid tumors refractory or intolerant to standard therapies or with no standard therapy available
  • Part 2: Patients with locally advanced or metastatic solid tumors eligible for nivolumab 240 mg administered every 2 weeks
  • Part 3: Patients with locally advanced unresectable or metastatic melanoma (excluding uveal melanoma) who received prior chemotherapy with dacarbazine and have no standard therapy
  • Patients with life expectancy of at least 3 months after starting study drug
  • Patients able to provide written informed consent in person
  • Negative pregnancy test before enrollment for females of childbearing potential
Not Eligible

You will not qualify if you...

  • Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
  • Pregnant or breastfeeding women, including those possibly pregnant
  • Patients unwilling or unable to comply with study procedures
  • Patients positive for HIV antibody
  • Patients positive for hepatitis B surface antigen (HBsAg)
  • Patients positive for hepatitis C virus RNA

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan, 467-8602

Actively Recruiting

2

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan, 811-1395

Actively Recruiting

3

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan, 060-8543

Actively Recruiting

4

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan, 860-8556

Actively Recruiting

5

Shinshu University Hospital

Matsumoto, Nagano, Japan, 390-8621

Actively Recruiting

6

Niigata Cancer Center Hospital

Niigata, Niigata, Japan, 951-8566

Actively Recruiting

7

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan, 350-1298

Actively Recruiting

8

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, Japan, 411-8777

Actively Recruiting

9

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan, 104-0045

Actively Recruiting

10

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan, 160-8582

Actively Recruiting

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Research Team

T

Toray Contact for Clinical Trial Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

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