Advanced or Metastatic Ovarian Cancer
Conditions
Brief 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
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
DRUGDAT-2645 tablet
Oral administration with 21 days each cycle
Sponsors
Danatlas Pharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate ( ORR ) | Approximately 2 years | Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Approximately 2 years | Defined as not meeting the criteria for progression and PR(partial response) |
| Duration of Response (DOR) | Approximately 2 years | 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. |
| Progression Free Survival (PFS) | Approximately 2 years | Progression- free survival (PFS) by RECIST V1.1 criteria- from the beginning of treatment to the progression of disease or death. |
| Overall Survival (OS) | Approximately 2 years | 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. |
| Adverse events | Approximately 2 years | The incidence of TEAE, TRAE, SAE, and clinically significant abnormalities (including laboratory tests, vital signs, physical examination, and electrocardiogram). |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645 | Approximately 2 years | PK parameter: AUC of DAT-2645 |
| Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645 | Approximately 2 years | PK parameter: Tmax of DAT-2645 |
| Maximal Plasma Concentration (Cmax) of DAT-2645 | Approximately 2 years | PK parameter: Cmax of DAT-2645 |
Countries
China
Contacts
CONTACTClinical Operation Director
CONTACTRegulatory Affairs Manager
Outcome results
None listed