A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDanatlas Pharmaceuticals Co., Ltd
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- DAT-2645 tablet
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov