A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DAT-2645 tablet.
- Who it may be relevant to
- Registry conditions: Advanced or Metastatic Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DAT-2645 in Patients With BRCA1/2 Deleterious Mutations or HRD-Positive Advanced/Metastatic Ovarian Cancer
Overview
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
Detailed description
This study is a multicenter, dose expansion, single-arm Phase II clinical trial. Administered once daily in the morning on an empty stomach at the recommended dose (RDE). Each treatment cycle consists of 21 days, with continuous administration until the first occurrence of disease progression, intolerable toxicity, withdrawal from the study, loss to follow-up, or initiation of new anticancer therapy. The trial plans to enroll 30 participants with advanced or metastatic ovarian cancer. The sponsor or investigator may terminate patient enrollment early based on interim efficacy and safety data.
Interventions
- Drug DAT-2645 tablet
Oral administration with 21 days each cycle
Primary outcome measures
- Objective response rate ( ORR ) [Time frame: Approximately 2 years]
Secondary outcome measures (8)
- Disease Control Rate (DCR) [Time frame: Approximately 2 years]
- Duration of Response (DOR) [Time frame: Approximately 2 years]
- Progression Free Survival (PFS) [Time frame: Approximately 2 years]
- Overall Survival (OS) [Time frame: Approximately 2 years]
- Adverse events [Time frame: Approximately 2 years]
- Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645 [Time frame: Approximately 2 years]
- Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645 [Time frame: Approximately 2 years]
- Maximal Plasma Concentration (Cmax) of DAT-2645 [Time frame: Approximately 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Research site — Guangzhou
- Research site — Beijing
Identifiers
NCT: NCT07652073 · DAT2645-Clin-201-CN