Ovarian CancerPhase 2NCT07370818
To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer
A Phase 2 study testing JPI-547 and Bevacizumab in people with Ovarian Cancer, run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- JPI-547 and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Feb 2026to 31 Dec 2031
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [High-grade serous carcinoma (HGSC), Grade 2/3 endometrioid carcinoma]
- Patients whose BRCA 1/2 gene mutation status and/or Homologous Recombination Deficiency (HRD) status.
- Patients who received platinum-based chemotherapy followed by PARP inhibitor maintenance therapy,
- Patients who had received chemotherapy before participating in the clinical trial and responded to platinum-based chemotherapy.
- Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Individuals with confirmed adequate hematological, renal, and hepatic function (laboratory tests may be repeated once during the screening period)
Who cannot join
- Patients with a history of severe drug hypersensitivity or hypersensitivity to the investigational drug, its components, or drugs within the same class.
- Individuals with dysphagia
- Patients with a confirmed specific medical history or a past surgical history.
- Patients with specific comorbidities or medical abnormalities.
- Pregnant women, lactating women, or women of childbearing potential who do not agree to use appropriate contraception during the clinical trial period and for 24 weeks after administration of the investigational medicinal product.
- Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
- Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine
Seoul
About this study
Official title: An Open-label, Dose-finding and Randomized Active-controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of JPI-547 With Bevacizumab Maintenance Therapy in Relapsed Ovarian Cancer Patients Previously Treated With PARP Inhibitor Maintenance Therapy and Responding to Last Platinum Chemotherapy
This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients
- Conditions
- Ovarian Cancer
- Being tested
- JPI-547, Bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPI-547Drug
taking JPI-547
BevacizumabDrug
administration Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| JPI-547+Bevacizumab | Experimental | Not described Receives: Drug: JPI-547; Drug: Bevacizumab |
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)
Measured: The dose-limiting toxicity evaluation window is 21 days
Part B: Progression free survival(PFS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start27 Feb 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370818
- Sponsor's protocol ID
- JPI-547-202
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-finding and Randomized Active-controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of JPI-547 With Bevacizumab Maintenance Therapy in Relapsed Ovarian Cancer Patients Previously Treated With PARP Inhibitor Maintenance Therapy and Responding to Last Platinum Chemotherapy
- ClinicalTrials.gov ID
- NCT07370818
- Acronym / sponsor ID
- JPI-547-202
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 27 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 aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JPI-547+Bevacizumab | Experimental | Drug: JPI-547, Drug: Bevacizumab |
| Bevacizumab | Experimental | Drug: Bevacizumab |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [High-grade serous carcinoma (HGSC), Grade 2/3 endometrioid carcinoma]
- Patients whose BRCA 1/2 gene mutation status and/or Homologous Recombination Deficiency (HRD) status.
- Patients who received platinum-based chemotherapy followed by PARP inhibitor maintenance therapy,
- Patients who had received chemotherapy before participating in the clinical trial and responded to platinum-based chemotherapy.
- Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (7 listed)
- Patients with a history of severe drug hypersensitivity or hypersensitivity to the investigational drug, its components, or drugs within the same class.
- Individuals with dysphagia
- Patients with a confirmed specific medical history or a past surgical history.
- Patients with specific comorbidities or medical abnormalities.
- Pregnant women, lactating women, or women of childbearing potential who do not agree to use appropriate contraception during the clinical trial period and for 24 weeks after administration of the investigational medicinal product.
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 |
|---|---|---|
| JPI-547taking JPI-547 | Drug | JPI-547+Bevacizumab |
| Bevacizumabadministration Bevacizumab | Drug | Bevacizumab, JPI-547+Bevacizumab |
Primary outcome
Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)
Time frame: The dose-limiting toxicity evaluation window is 21 days
Part B: Progression free survival(PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 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 27 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JPI-547 and Bevacizumab in people with Ovarian Cancer, run by Onconic Therapeutics Inc. at 1 site in South Korea.
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 6 inclusion and 7 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 Onconic Therapeutics Inc. (+ 82-2-3454-0780, onconictherapeutics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D) (time frame: The dose-limiting toxicity evaluation window is 21 days). The study lists 2 primary outcomes in all. 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 27 Jan 2026.