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

NCT05423262 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-13

No results posted yet for this study

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

Conditions

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)

Sponsors & Collaborators

  • Toray Industries, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423262 on ClinicalTrials.gov