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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral administration with 21 days each cycle
Research site
Guangzhou, Guangdong, China
Research site
Beijing, China
Objective response rate ( ORR )
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
Time frame: Approximately 2 years
Disease Control Rate (DCR)
Defined as not meeting the criteria for progression and PR(partial response)
Time frame: Approximately 2 years
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 years
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 years
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 years
Adverse events
The incidence of TEAE, TRAE, SAE, and clinically significant abnormalities (including laboratory tests, vital signs, physical examination, and electrocardiogram).
Time frame: Approximately 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645
PK parameter: AUC of DAT-2645
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Time frame: Approximately 2 years
Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645
PK parameter: Tmax of DAT-2645
Time frame: Approximately 2 years
Maximal Plasma Concentration (Cmax) of DAT-2645
PK parameter: Cmax of DAT-2645
Time frame: Approximately 2 years