Clinical trial · Interventional
A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer
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
NCT07652073CI-TRIAL-00115844not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Ovarian Cancer | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DAT-2645 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DAT-2645 tablet
- description
- Monotherapy under the recommended dose (RDE)
- interventionNames
- Drug: DAT-2645 tablet
Primary outcomes (1)
- measure
- Objective response rate ( ORR )
- timeFrame
- Approximately 2 years
- description
- Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
Secondary outcomes (8)
- measure
- Disease Control Rate (DCR)
- timeFrame
- Approximately 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.