An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors
Trial Parameters
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Brief Summary
This is a Phase Ib/II clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart /olaparib /topotecanfor patients with advanced solid tumors. The Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart /olaparib/topotecanin selected advanced solid tumor indications. The study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.
Eligibility Criteria
Inclusion Criteria: * -Voluntarily participate in this study and sign the informed consent form. * At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive). * Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows: * Phase Ib :Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II. * Phase II Study:Based on different combination therapy groups, subjects with the following specific tumor types (different population cohorts): TCC1727 combined with Benmelstobart Group: The study will enroll subjects with advanced solid tumors lacking standard therapies, including bu