A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer

This is a Phase II, multicenter, single-arm dose expansion trial planned to enroll up to 30 subjects with advanced or metastatic ovarian cancer. The Objective is to conduct a preliminary evaluation of the efficacy, the safety, tolerability and PK profile of DAT-2645

Inclusion Criteria: * sign a written informed consent form * At least 18 years of age (inclusive) * Epithelial ovarian cancer confirmed by histopathology or cytopathology * BRCA1/2 mutation or HRD-positive status * Patients who have failed standard treatment or are unable to tolerate standard treatment * Patients must have received no more than five prior treatment lines * At least one measurable lesion * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Bone marrow reserve and organ function must meet the requirements * Negative result on a blood pregnancy test for a woman of childbearing age Exclusion Criteria: * Received small-molecule chemotherapy or targeted therapy within 2 weeks or 5 half-lives prior to the first dose * Received treatment with an anticancer biological therapy within 4 weeks prior to the first dose * Underwent major surgery within 4 weeks prior to the first dose * Has previously received treatment with a PARG inhibitor * Inadequate response to previous PARP inhibitor maintenance therapy * With central nervous system metastases * Patients with clinically significant cardiovascular or cerebrovascular diseases * Uncontrolled active infections requiring intravenous antibiotics or hospitalization * Adverse reactions from prior anticancer therapy have not yet resolved to a grade ≤1