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.
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Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)
Timeframe: At the end of Cycle 1 (each cycle is 21 days), and at the end of every subsequent cycle (each cycle is 21 days) for approximately 10 months (or earlier if patient discontinues the study)
Phase 2: Objective Response Rate (ORR) by independent central review
Timeframe: Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease.