Phase IbII Study of TCC1727 Combined With Benmelstobart, Olaparib, or Topotecan for Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a Phase IbII clinical trial to evaluate the use of TCC1727 combined with benmelstobart, olaparib, or topotecan in patients with advanced solid tumors. The Phase Ib part focuses on finding the right dose of TCC1727 with benmelstobart, while the Phase II expansion will assess the safety and effectiveness of these combinations in specific tumor types including non-small cell lung cancer, endometrial cancer, ovarian cancer, small cell lung cancer, and other advanced solid tumors. This study aims to provide additional treatment options for patients who have progressed after or cannot tolerate standard therapies. The trial includes three dose levels of TCC1727 tablets taken orally twice daily in 21-day cycles, combined with benmelstobart administered by intravenous infusion every 3 weeks until the disease progresses. Initially, the combination of TCC1727 and benmelstobart is prioritized, with potential evaluation of combinations including olaparib or topotecan based on emerging clinical data. Participants continue treatment as long as they benefit or have no unacceptable side effects. Participants will undergo evaluations to monitor treatment-related side effects, tumor response using imaging criteria, and pharmacokinetic assessments of TCC1727 at specified intervals. Safety monitoring includes checking blood counts, organ function, and heart health before and during treatment. The main outcomes include identifying dose-limiting toxicities, determining the recommended dose for Phase II, and measuring response rates, disease control, survival, and adverse events. The study is planned to continue until mid-2029, with ongoing assessments throughout the treatment period.

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors