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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAS0953/HM06 — DRUG
  Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
• TAS0953/HM06 — DRUG
  Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days

Study Details

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 Dates

Start date

Dec 16, 2020

Status verified

Feb 2026

Primary completion

Mar 31, 2030

Completion

Mar 31, 2031

Study Design

Enrollment

244 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: TAS0953/HM06 Phase 1
  Dose escalation and dose expansion until recommended Phase 2 dose determined
• Experimental: TAS0953/HM06 Phase 2
  Treatment phase at recommended Phase 2 dose in three different populations

Primary Outcome Measure

Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]

Central Contacts

• Kazuo Koba
  +08 8010113399
  [email protected]

Locations (9)

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