NCT04683250

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-12-16
• Primary completion: 2030-03-01
• Completion: 2031-03-01
• First posted: 2020-12-24
• Last updated: 2026-03-03

Locations

21 sites across 3 countries: United States, Japan, South Korea

Regulatory

• FDA-regulated drug study