RecruitingPhase 1Phase 2NCT04683250

Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities

Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities

Sponsor

Taiho Pharmaceutical Co., Ltd.

Enrollment

244 participants

Start Date

Dec 16, 2020

Study Type

INTERVENTIONAL

Conditions

RET-altered Non Small Cell Lung Cancer RET-altered Solid Tumors

Summary

Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called TAS0953/HM06 that targets a specific gene mutation called a RET abnormality, found in some solid tumors including certain lung cancers and thyroid cancers. The study is finding the right dose (phase I) and testing how well it works. **You may be eligible if...** - You are an adult with an advanced solid tumor that has a RET gene mutation or rearrangement (confirmed by tissue or blood biopsy) - You are in good overall health (ECOG 0 or 1) - Your blood, liver, and kidney function are adequate - For the dose-finding phase: your disease is measurable on scans, or you have evaluable disease **You may NOT be eligible if...** - You do not have a confirmed RET gene abnormality - You are in poor health overall - Your organ function does not meet the required thresholds 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

DRUGTAS0953/HM06

Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days

DRUGTAS0953/HM06

Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days

Locations(21)

Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Center

Stanford, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

START Midwest - Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Shizuoka Cancer Center

Shizuoka, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Kurashiki Central Hospital

Okayama, Japan

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT04683250