To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer

January 21, 2026 updated by: Onconic Therapeutics Inc.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Drug: Bevacizumab
administration Bevacizumab
Experimental: JPI-547+Bevacizumab
Drug: JPI-547
taking JPI-547
Drug: Bevacizumab
administration Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)
Time Frame: The dose-limiting toxicity evaluation window is 21 days
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onconic Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 27, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPI-547-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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