Starting soon
Phase 2
A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer
Condition(s) studied
Advanced or Metastatic Ovarian Cancer
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Research site |
Guangzhou |
Guangdong |
|
| Research site |
Beijing |
China |
|
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