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Not yet recruitingNCT07652073Updated Jun 25, 2026

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

A Phase 2 interventional study of DAT-2645 tablet in Advanced or Metastatic Ovarian Cancer, sponsored by Danatlas Pharmaceuticals Co., Ltd. Not yet recruiting at 2 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Danatlas Pharmaceuticals Co., Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Advanced or Metastatic Ovarian Cancer

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03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

This is the only study on the registry with Danatlas Pharmaceuticals Co., Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    DAT-2645 tablet

    Monotherapy under the recommended dose (RDE)

    Drug: DAT-2645 tablet

Interventions

  • DrugDAT-2645 tablet

    Oral administration with 21 days each cycle

06

What researchers measure

Primary outcomes

  1. Objective response rate ( ORR )

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

    Time frame: Approximately 2 years

Secondary outcomes

  1. Disease Control Rate (DCR)

    Defined as not meeting the criteria for progression and PR(partial response)

    Time frame: Approximately 2 years

  2. 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

  3. 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

  4. 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

  5. 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

  6. Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645

    PK parameter: AUC of DAT-2645

    Time frame: Approximately 2 years

  7. Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645

    PK parameter: Tmax of DAT-2645

    Time frame: Approximately 2 years

  8. Maximal Plasma Concentration (Cmax) of DAT-2645

    PK parameter: Cmax of DAT-2645

    Time frame: Approximately 2 years

07

Study locations

2 sites
  • Research site
    Guangzhou, Guangdong 510050, China
  • Research site
    Beijing, 100021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07652073
Lead sponsor
Danatlas Pharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Jun 25, 2026

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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