RecruitingPhase 1Phase 2NCT05423262

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

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


Sponsor

Toray Industries, Inc

Enrollment

49 participants

Start Date

Jul 6, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TRK-950, which is designed to help the immune system fight cancer, in patients with advanced or metastatic solid tumors. Some parts of the study involve TRK-950 alone, some in combination with an existing immunotherapy (nivolumab), and one part targets advanced melanoma. **You may be eligible if:** - You are at least 18 years old - You have a confirmed advanced or metastatic solid tumor - Your cancer has either not responded to standard treatments or no standard treatment exists - You have a life expectancy of at least 3 months - You are able to give written consent - You have a negative pregnancy test if you could become pregnant **You may NOT be eligible if:** - You have an active, uncontrolled bacterial, viral, or fungal infection - You are pregnant or breastfeeding - You test positive for HIV - You are unwilling or unable to follow the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTRK-950

5 or 10 mg/kg administered intravenously over 60 minutes (weekly)

BIOLOGICALTRK-950

10 mg/kg administered intravenously over 60 minutes (weekly)

BIOLOGICALTRK-950

20 mg/kg administered intravenously over 60 minutes (bi-weekly)

DRUGNivolumab

240 mg administered intravenously over 30 minutes (bi-weekly)

BIOLOGICALTRK-950

10 mg/kg administered Intravenously over 60 minutes (weekly)


Locations(10)

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

View Full Details on ClinicalTrials.gov

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NCT05423262


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