OvariancancerPhase 2NCT07339553
Clinical Study of EZH2 Inhibitor Combined With PARP Inhibitor in the Treatment of Patients With Advanced or Recurrent Epithelial Ovarian Cancer.
A Phase 2 study testing Treatment in people with Ovariancancer and Platinum-sensitive Recurrent, run by Peking University Third Hospital.
Trial summary
This study evaluates the efficacy and safety of Zeprumetostat in combination with Fuzuloparib for the treatment of patients with advanced or recurrent ovarian epithelial carcinoma, with the primary endpoint being Objective Response Rate (ORR). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovariancancer, Platinum-sensitive Recurrent
- What is being tested?
- Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2026to 26 Feb 2029
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Histologically or cytologically confirmed ovarian carcinoma with FIGO Stage III-IV disease, or recurrent ovarian epithelial carcinoma (any stage or timing of recurrence), with genetic testing results indicating BRCA1/2 wild-type.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (computed tomography scan showing the longest diameter of a non-lymph node tumor lesion is no less than 10 millimeters, or the short axis of a lymph node lesion is no less than 15 millimeters), or abnormal cancer antigen 125 levels, or presence of ascites, as confirmed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score between 0 and 2; expected survival of at least 3 months.
- Adequate function of major organs, with screening laboratory test results meeting the following requirements:
- Complete Blood Count criteria must be met:
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- Hemoglobin ≥ 80 grams per liter; B. Absolute neutrophil count ≥ 1.5 × 10⁹ per liter; C. Platelet count ≥ 80 × 10⁹ per liter.
- Biochemistry criteria must meet the following standards:
- Total bilirubin < 1.5 times the upper limit of normal; B. Alanine aminotransferase and aspartate aminotransferase < 2.5 times the upper limit of normal, and < 5 times the upper limit of normal for patients with liver metastases; C. Serum creatinine ≤ 1.5 times the upper limit of normal or endogenous creatinine clearance > 60 milliliters per minute (calculated by the Cockcroft-Gault formula); D. Urine protein < 2+ or 24-hour urinary protein quantification < 1 gram.
- Signed written informed consent, with anticipated good compliance to the study protocol.
- After completion of the first phase (Fuzuloparib monotherapy), subjects who experience hematological toxicity may proceed to the second phase (combination therapy) only after the investigator determines that the hematological toxicity has recovered to meet the enrollment criteria.
Who cannot join
- Patients with active brain metastases.
- Use of immunosuppressive drugs within the 28 days prior to enrollment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day of prednisolone or equivalent doses of other corticosteroids for physiological replacement).
- Systemic treatment with Chinese herbal medicines with approved anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin; except for local use in controlling pleural effusion) within 2 weeks prior to the first dose.
- History of severe cardiovascular diseases: myocardial ischemia of grade II or higher or myocardial infarction, poorly controlled arrhythmias (including corrected QT interval ≥ 470 ms in females); cardiac dysfunction of grade III to IV according to the New York Heart Association classification (see Appendix 3), or left ventricular ejection fraction less than 50% as indicated by cardiac ultrasound.
- Concurrent severe infection within 4 weeks prior to the first dose, or unexplained fever > 38.5°C during screening/prior to the first dose; or major surgical procedure within 3 weeks prior to the first dose.
- Presence of active autoimmune disease or immunodeficiency, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.
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- Subjects requiring systemic therapy such as bronchodilators with suboptimal asthma control.
- Subjects who have undergone or plan to undergo solid organ or hematopoietic system transplantation during the study period (except for corneal transplantation).
- Current participation in an interventional clinical study, or treatment with other investigational drugs or devices within 4 weeks prior to the first dose; or not having fully recovered from toxicities and/or complications caused by any previous intervention prior to the first dose.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg despite optimal medical therapy).
- Abnormal coagulation function (international normalized ratio > 1.5, or prothrombin time > upper limit of normal + 4 seconds, or activated partial thromboplastin time > 1.5 times the upper limit of normal), bleeding tendency, or current use of thrombolytic or anticoagulant therapy.
- History of psychoactive drug abuse and inability to abstain, or history of mental disorders.
- History of hereditary or acquired bleeding disorders or coagulation dysfunction (subject to investigator's judgment on eligibility).
- Concomitant use of strong cytochrome P450 3A4 inhibitors (e.g., itraconazole, telithromycin, clarithromycin, etc.), moderate cytochrome P450 3A4 inhibitors (e.g., ciprofloxacin, erythromycin, fluconazole, etc.), strong cytochrome P450 3A4 inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampin, etc.), or moderate cytochrome P450 3A4 inducers (e.g., bosentan, modafinil, etc.). Required washout period prior to initiation of study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Prior exposure to other enhancer of zeste homolog 2 inhibitors.
- History of cerebrovascular accident or transient ischemic attack within the past 6 months.
- Any other condition that, in the judgment of the investigator, increases the risk associated with study participation or administration of the investigational product, and would make the patient unsuitable for inclusion in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Study of Zeprumetostat Combined With Fuzuloparib in the Treatment of Patients With Advanced or Recurrent Ovarian Epithelial Carcinoma
This study evaluates the efficacy and safety of Zeprumetostat in combination with Fuzuloparib for the treatment of patients with advanced or recurrent ovarian epithelial carcinoma, with the primary endpoint being Objective Response Rate (ORR).
- Conditions
- Ovariancancer, Platinum-sensitive Recurrent
- Being tested
- Treatment
- Keywords
- EZH2 Inhibitor, PARP Inhibitor, SHR2554, Zeprumetostat Tablets, Platinum-sensitive recurrent ovarian cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence.
Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence.
Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur. Receives: Drug: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of patients achieving tumour volume reduction meeting predetermined criteria (RECIST 1.1) and maintaining this reduction for a specified duration (typically at least four weeks), encompassing both complete response (CR) and partial response (PR).
Measured: 12 months
Secondary outcomes (2)
Progression-Free Survival
The time from the start of treatment to tumour progression or death from any cause, whichever occurs first.
Measured: 24 months
Overall Survival
The time from the commencement of treatment to death from any cause.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start4 Jan 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion26 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OvariancancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence. Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyan Guo, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339553
- Sponsor's protocol ID
- M20250852
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Zeprumetostat Combined With Fuzuloparib in the Treatment of Patients With Advanced or Recurrent Ovarian Epithelial Carcinoma
- ClinicalTrials.gov ID
- NCT07339553
- Acronym / sponsor ID
- M20250852
- Conditions
- Ovariancancer, Platinum-sensitive Recurrent
- Keywords
- EZH2 Inhibitor, PARP Inhibitor, SHR2554, Zeprumetostat Tablets, Platinum-sensitive recurrent ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 4 Jan 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 26 Feb 2029 (estimated)
- First posted
- 14 Jan 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 study evaluates the efficacy and safety of Zeprumetostat in combination with Fuzuloparib for the treatment of patients with advanced or recurrent ovarian epithelial carcinoma, with the primary endpoint being Objective Response Rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence. Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: TreatmentPhase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence. Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 75 years.
- Histologically or cytologically confirmed ovarian carcinoma with FIGO Stage III-IV disease, or recurrent ovarian epithelial carcinoma (any stage or timing of recurrence), with genetic testing results indicating BRCA1/2 wild-type.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (computed tomography scan showing the longest diameter of a non-lymph node tumor lesion is no less than 10 millimeters, or the short axis of a lymph node lesion is no less than 15 millimeters), or abnormal cancer antigen 125 levels, or presence of ascites, as confirmed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score between 0 and 2; expected survival of at least 3 months.
- Adequate function of major organs, with screening laboratory test results meeting the following requirements:
Key exclusion criteria (17 listed)
- Patients with active brain metastases.
- Use of immunosuppressive drugs within the 28 days prior to enrollment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day of prednisolone or equivalent doses of other corticosteroids for physiological replacement).
- Systemic treatment with Chinese herbal medicines with approved anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin; except for local use in controlling pleural effusion) within 2 weeks prior to the first dose.
- History of severe cardiovascular diseases: myocardial ischemia of grade II or higher or myocardial infarction, poorly controlled arrhythmias (including corrected QT interval ≥ 470 ms in females); cardiac dysfunction of grade III to IV according to the New York Heart Association classification (see Appendix 3), or left ventricular ejection fraction less than 50% as indicated by cardiac ultrasound.
- Concurrent severe infection within 4 weeks prior to the first dose, or unexplained fever > 38.5°C during screening/prior to the first dose; or major surgical procedure within 3 weeks prior to the first dose.
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 |
|---|---|---|
| TreatmentPhase 1: Fuzuloparib Monotherapy Dose: 150 mg, twice daily (bid), orally (po). Duration: Administration for 2 to 4 weeks, until hematological toxicity recovers to pre-enrollment criteria, after which Phase 2 combination therapy may commence. Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po. Duration: Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified reasons for treatment discontinuation occur. | Drug | Treatment group |
Primary outcome
Objective response rate
Time frame: 12 months
The proportion of patients achieving tumour volume reduction meeting predetermined criteria (RECIST 1.1) and maintaining this reduction for a specified duration (typically at least four weeks), encompassing both complete response (CR) and partial response (PR).
2 secondary outcomes
Progression-Free Survival
Time frame: 24 months
Overall Survival
Time frame: 36 months
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment in people with Ovariancancer and Platinum-sensitive Recurrent, run by Peking University Third Hospital.
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 11 inclusion and 17 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hongyan Guo, Doctor (+86 188 1158 3538, bysyghy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 12 months). 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 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.