A Study of DAT-2645 in Patients With BRCA1/2 Mutations or... | NCT07652073

Studies
A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer

NCT07652073

Sponsor

Danatlas Pharmaceuticals Co., Ltd

Status

Not yet recruiting

Last Update Posted

Jun 25, 2026Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Advanced or Metastatic Ovarian Cancer

Interventions

DAT-2645 tablet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Mar 30, 2028Estimated

First Submitted Date

Jun 11, 2026

First Submission Date that Met QC Criteria

Jun 11, 2026

First Posted Date

Jun 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2026

Last Update Posted Date

Jun 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DAT-2645 tablet	Experimental	Monotherapy under the recommended dose (RDE)	Drug: DAT-2645 tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DAT-2645 tablet	Drug	Oral administration with 21 days each cycle	DAT-2645 tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate ( ORR )	Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1	Approximately 2 years

Secondary Outcomes

Measure	Description	Time Frame
Disease Control Rate (DCR)	Defined as not meeting the criteria for progression and PR(partial response)	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Operation Director	Contact	+86-10-67803200		information@danatlas.com
Regulatory Affairs Manager	Contact	+86-13717825107		Huixian.chen@danatlas.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Guangzhou	Guangdong	510050	China
Research site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases