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
Sponsors and collaborators
Taiho Pharmaceutical Co., Ltd.
Lead sponsor
Linical Co., Ltd.
Collaborator