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

A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DAT-2645 in Patients With BRCA1/2 Deleterious Mutations or HRD-Positive Advanced/Metastatic Ovarian Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced or Metastatic Ovarian Cancer
• Intervention / Treatment: Drug: DAT-2645 tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Operation Director; Phone Number: +86-10-67803200; Email: information@danatlas.com
• Study Contact Backup: Name: Regulatory Affairs Manager; Phone Number: +86-13717825107; Email: Huixian.chen@danatlas.com

Study Locations

• China
  • Beijing, China, 100021
    • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510050
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAT-2645 tablet; Monotherapy under the recommended dose (RDE)	Drug: DAT-2645 tablet; Oral administration with 21 days each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	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.	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.	Approximately 2 years
Adverse events	The incidence of TEAE, TRAE, SAE, and clinically significant abnormalities (including laboratory tests, vital signs, physical examination, and electrocardiogram).	Approximately 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645	PK parameter: AUC of DAT-2645	Approximately 2 years
Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645	PK parameter: Tmax of DAT-2645	Approximately 2 years
Maximal Plasma Concentration (Cmax) of DAT-2645	PK parameter: Cmax of DAT-2645	Approximately 2 years

Collaborators and Investigators

• Sponsor: Danatlas Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms
• Other Study ID Numbers: DAT2645-Clin-201-CN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No