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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
DAT-2645 tablet
DrugOral administration with 21 days each cycle
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: DAT-2645 tabletExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate ( ORR )
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
Time frame
Approximately 2 yearsSecondary outcomes
1
Disease Control Rate (DCR)
Defined as not meeting the criteria for progression and PR(partial response)
Time frame
Approximately 2 years2
Duration of Response (DOR)
DOR(duration of response) per RECIST v1.1(Response Evaluation Criteria in Solid Tumors). Measured in CT/MRI image from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.
Time frame
Approximately 2 years3
Progression Free Survival (PFS)
Progression- free survival (PFS) by RECIST V1.1 criteria- from the beginning of treatment to the progression of disease or death.
Time frame
Approximately 2 years4
Overall Survival (OS)
Overall Survival (OS) was defined as the time interval between a patient randomized and death from any cause or the end of the last follow-up date.
Time frame
Approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: