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Starting soon Phase 2

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

NCT07652073 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-06-15
Last updated
2026-06-25

Condition(s) studied

Advanced or Metastatic Ovarian Cancer

Investigational drug(s) / intervention(s)

DAT-2645 tablet →

DAT-2645 tablet: Oral administration with 21 days each cycle

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective response rate ( ORR ) — Approximately 2 years
    Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1

Trial sites (2)

FacilityCityRegionStatus
Research site Guangzhou Guangdong
Research site Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652073 on ClinicalTrials.gov ↗ ← All trials in China