Phase 12 Study of TAS0953HM06, a Selective RET Inhibitor, in Adults With Advanced Solid Tumors Having RET Gene Abnormalities

What this Trial Is About

Researchers are studying the safety, how the body processes, and the effects of TAS0953HM06, a selective RET inhibitor, in adults with advanced solid tumors that have specific RET gene abnormalities. The study is conducted in two phases Phase 1 focuses on finding the highest dose patients can tolerate and the best dose for Phase 2, while Phase 2 evaluates how well this dose works. This research is sponsored by Taiho Pharmaceutical Co., Ltd. and spans both Phase 1 and Phase 2 clinical trial stages. In the first phase, participants receive TAS0953HM06 orally, starting at 20 mg twice daily, with continuous daily dosing in 21-day cycles. Dose escalation and expansion continue until the appropriate Phase 2 dose is determined. In the second phase, participants take the recommended dose twice daily in similar 21-day cycles. Treatment is given continuously during both phases to assess safety and efficacy across different patient groups, including those with prior exposure to similar inhibitors and those without. Throughout the study, participants undergo regular assessments such as physical exams, blood tests, and imaging scans to monitor tumor response and drug levels. In Phase 1, dose tolerance and pharmacokinetics are evaluated at the end of the first cycle and over approximately 10 months. Phase 2 participants are monitored for tumor response every 6 weeks for 6 months, then every 9 weeks during treatment, with follow-up extending up to two years. Safety is closely tracked through adverse event reporting and heart monitoring, with additional evaluations after treatment ends.

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