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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Pharmaceutical Co., Ltd.

About this trial

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 criteria

Qualifiers

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

Advanced solid tumors

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TAS0953/HM06
  • TAS0953/HM06

Treatment groups

244 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Taiho Pharmaceutical Co., Ltd.

Lead sponsor

Linical Co., Ltd.

Collaborator