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

Recruiting now · Phase 1/Phase 2

Conditions studied: RET-altered Non Small Cell Lung Cancer, RET-altered Solid Tumors

In brief

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.

Key facts

Study ID

NCT04683250

Run by

Taiho Pharmaceutical Co., Ltd.

People needed

244

Starts

2020-12-16

Expected to finish

2031-03-01

Last updated by the study team

2026-03-03

Who can join

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

You may qualify if…

• Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
• Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block or cell pellet is also acceptable.
• Adequate hematopoietic, hepatic and renal function
• Phase I Dose-Escalation - Specific inclusion criteria:
• Advanced solid tumors
• Measurable and/or non-measurable disease as determined by RECIST 1.1
• If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic.
• Phase I Dose-Expansion - Specific inclusion criteria:
• Patient with RET gene fusion :
• Cohort 1, 3: locally advanced or metastatic NSCLC patients naïve to RET selective inhibitors and no prior systemic anti-cancer treatment. Patients who have been treated with neo-adjuvant or adjuvant chemotherapy may be included if it has been completed at least 6 months prior to the first dose of the study.
• Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors.
• Measurable disease as determined by RECIST 1.1
• If patient has brain and/or leptomeningeal metastases,(s)he should have:
• asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
• asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
• Phase II :
• Available RET-gene abnormalities determined on tissue or liquid biopsy
• Locally advanced or metastatic:
• NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;
• NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors
• patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
• Measurable disease as determined by RECIST 1.1
• If patient has brain and/or leptomeningeal metastases,(s)he should have:

You may not qualify if…

• Common exclusion criteria for Phase 1 and Phase 2
• Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug
• Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.
• Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.
• Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.
• QT interval corrected using Fridericia's formula (QTcF) >470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP
• Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug.
• Phase I Dose-Expansion - and Phase II specific exclusion criteria:
• Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.

Where it is running

• Samsung Medical Center — Seoul, South Korea (enrolling)
• Okayama University Hospital — Okayama, Okayama-ken, Japan (enrolling)
• Kansai Medical University Hospital — Hirakata-shi, Osaka, Japan (enrolling)
• Osaka International Cancer Institute — Osaka, Osaka, Japan (enrolling)
• Shizuoka Cancer Center — Shizuoka, Shizuoka, Japan (enrolling)
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
• The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (enrolling)
• National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (enrolling)
• Kanagawa Cancer Center — Kanagawa, Japan (enrolling)
• Kurashiki Central Hospital — Okayama, Japan (enrolling)
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (enrolling)
• Tohoku University Hospital — Sendai, Miyagi, Japan (enrolling)
• 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
• Chao Family Comprehensive Cancer Center — Orange, California, United States

Full record on ClinicalTrials.gov

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