Advanced or Metastatic Ovarian CancerPhase 2NCT07652073
A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer
A Phase 2 study testing DAT-2645 tablet in people with Advanced or Metastatic Ovarian Cancer, run by Danatlas Pharmaceuticals Co., Ltd at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced or Metastatic Ovarian Cancer
- What is being tested?
- DAT-2645 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2026to 30 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Research site
Beijing, 100021
Research site
Guangzhou, Guangdong, 510050
About this study
Official title: 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
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.
- Conditions
- Advanced or Metastatic Ovarian Cancer
- Being tested
- DAT-2645 tablet
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAT-2645 tabletDrug
Oral administration with 21 days each cycle
| Study group | Role | What they receive |
|---|---|---|
| DAT-2645 tablet | Experimental | Monotherapy under the recommended dose (RDE) Receives: Drug: DAT-2645 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate ( ORR )
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
Measured: Approximately 2 years
Secondary outcomes (8)
Disease Control Rate (DCR)
Defined as not meeting the criteria for progression and PR(partial response)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 2 years
Adverse events
The incidence of TEAE, TRAE, SAE, and clinically significant abnormalities (including laboratory tests, vital signs, physical examination, and electrocardiogram).
Measured: Approximately 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645
PK parameter: AUC of DAT-2645
Measured: Approximately 2 years
Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645
PK parameter: Tmax of DAT-2645
Measured: Approximately 2 years
Maximal Plasma Concentration (Cmax) of DAT-2645
PK parameter: Cmax of DAT-2645
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danatlas Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652073
- Sponsor's protocol ID
- DAT2645-Clin-201-CN
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07652073
- Acronym / sponsor ID
- DAT2645-Clin-201-CN
- Conditions
- Advanced or Metastatic Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Danatlas Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAT-2645 tablet | Experimental | Drug: DAT-2645 tabletMonotherapy under the recommended dose (RDE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAT-2645 tabletOral administration with 21 days each cycle | Drug | DAT-2645 tablet |
Primary outcome
Objective response rate ( ORR )
Time frame: Approximately 2 years
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
8 secondary outcomes
Disease Control Rate (DCR)
Time frame: Approximately 2 years
Duration of Response (DOR)
Time frame: Approximately 2 years
Progression Free Survival (PFS)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Adverse events
Time frame: Approximately 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645
Time frame: Approximately 2 years
Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645
Time frame: Approximately 2 years
Maximal Plasma Concentration (Cmax) of DAT-2645
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAT-2645 tablet in people with Advanced or Metastatic Ovarian Cancer, run by Danatlas Pharmaceuticals Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operation Director (+86-10-67803200, information@danatlas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate ( ORR ) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.