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

Starting soon · Phase 2

Conditions studied: Advanced or Metastatic Ovarian Cancer

In brief

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

Key facts

Study ID

NCT07652073

Run by

Danatlas Pharmaceuticals Co., Ltd

People needed

30

Starts

2026-06-15

Expected to finish

2028-03-30

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research site — Guangzhou, Guangdong, China
• Research site — Beijing, China

Full record on ClinicalTrials.gov

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