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

NCT04683250 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

TAS0953/HM06

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

DRUG

TAS0953/HM06

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

Sponsors & Collaborators

  • Linical Co., Ltd.

    collaborator INDUSTRY

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2030-03-31
Completion
2031-03-31
FDA Drug
Yes

Countries

  • United States
  • Japan
  • South Korea

Study Locations

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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 NCT04683250 on ClinicalTrials.gov