NCT07370818

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
69mo left

Started Feb 2026

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Feb 2026Dec 2031

First Submitted

Initial submission to the registry

January 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 27, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

January 12, 2026

Last Update Submit

January 21, 2026

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

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

    The dose-limiting toxicity evaluation window is 21 days

  • Part B: Progression free survival(PFS)

    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 Arms (2)

JPI-547+Bevacizumab

EXPERIMENTAL
Drug: JPI-547Drug: Bevacizumab

Bevacizumab

EXPERIMENTAL
Drug: Bevacizumab

Interventions

JPI-547DRUG

taking JPI-547

JPI-547+Bevacizumab
BevacizumabDRUG

administration Bevacizumab

BevacizumabJPI-547+Bevacizumab

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Onconic Therapeutics Inc.

CONTACT

+ 82-2-3454-0780onconictherapeutics@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 27, 2026

Study Start

February 27, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

KR(1)