Clinical trial · Interventional
To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer
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
NCT07370818CI-TRIAL-00101733not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| JPI-547 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JPI-547+Bevacizumab
- interventionNames
- Drug: JPI-547
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Bevacizumab
- interventionNames
- Drug: Bevacizumab
Primary outcomes (2)
- measure
- Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)
- timeFrame
- The dose-limiting toxicity evaluation window is 21 days
- measure
- Part B: Progression free survival(PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.