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NCT Number: NCT07370818

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

This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JPI-547

Drug

taking JPI-547

Bevacizumab

Drug

administration Bevacizumab

Primary outcomes

  1. Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)

    Time frame: The dose-limiting toxicity evaluation window is 21 days

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Onconic Therapeutics Inc.

CONTACT

[email protected]

+ 82-2-3454-0780

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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