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

NCT07652073 | Not Yet Recruiting Phase 2

• 1 other identifier: DAT2645-Clin-201-CN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Advanced or Metastatic Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate ( ORR )

  Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1

  Approximately 2 years

Secondary Outcomes (8)

• Disease Control Rate (DCR)

  Approximately 2 years

• Duration of Response (DOR)

  Approximately 2 years

• Progression Free Survival (PFS)

  Approximately 2 years

• Overall Survival (OS)

  Approximately 2 years

• Adverse events

  Approximately 2 years

Study Arms (1)

DAT-2645 tablet

EXPERIMENTAL

Monotherapy under the recommended dose (RDE)

Drug: DAT-2645 tablet

Interventions

DAT-2645 tablet DRUG

Oral administration with 21 days each cycle

DAT-2645 tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danatlas Pharmaceuticals Co., Ltd: lead

Study Sites (2)

Research site

Guangzhou, Guangdong, 510050, China

Location

Research site

Beijing, 100021, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Clinical Operation Director

CONTACT

+86-10-67803200; information@danatlas.com

Regulatory Affairs Manager

CONTACT

+86-13717825107; Huixian.chen@danatlas.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)