Taiho Pharmaceutical Co., Ltd.
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.
Ages Eligible for Study: \- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region) Inclusion Criteria: Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion: * 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 Phase I Dose-Escalation - Specific inclusion c…
Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days