Clinical trial · Interventional
A Study to Evaluate the Efficacy and Safety of JPI-547 in Platinum-resistant, Advanced/Relapsed Ovarian Cancer Subjects Previously Treated With a PARP Inhibitor
A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of JPI-547, a PARP/TNKS Dual Inhibitor in Platinum-resistant, Advanced/Relapsed Ovarian Cancer Subjects Previously Treated With a PARP Inhibitor
NCT05475184CI-TRIAL-00080218unknownPhase 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)
To evaluate the efficacy and safety of JPI-547, a PARP/TNKS dual inhibitor in Platinum-resistant, advanced/relapsed ovarian cancer subjects previously treated with a PARP inhibitor
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JPI-547 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JPI-547
- interventionNames
- Drug: JPI-547
Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- From date of study enroll until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
- description
- To evaluate the objective response rate (ORR) in accordance with the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Secondary outcomes (1)
- measure
- Anti-tumor activity
- timeFrame
- From date of study enroll until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced/metastatic high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer\*: 1. who has undergone ≥2 previous chemotherapy regimen; 2. with confirmed platinum resistance\*\*; 3. ≥3 month PARP inhibitor treatment history; 4. confirmed BRCA1/2 mutation \*\*\* or HRD \*\*\*\* * Subjects with at least one measurable lesion in accordance with RECIST v1.1 * Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Subjects with life expectancy ≥12 weeks * Patients with adequate hematologic, kidney, and liver functions confirmed using the following criteria (retesting of laboratory tests is allowed once during screening) * Subjects who voluntarily decided to participate in this study after being fully informed and gave informed consent Exclusion Criteria: * Subjects who meet any of the following conditions cannot participate in this study: 1. Subjects with a history of severe drug hypersensitivity or the hypersensitivity to IP and its ingredients or similar drugs 2. Subjects with dysphagia 3. Subjects confirmed with the following medical or surgical/procedural history: * Primary malignant tumor other than ovarian cancer diagnosed or treated within 24 months prior to baseline (individuals with successfully treated cutaneous basal/squamous cell carcinoma are eligible for enrollment) * Major surgery requiring general anesthesia or respiratory support within 4 weeks prior to baseline (2 weeks for video-assisted thoracoscopic surgery \[VATS\] or open-and-closed \[ONC\] surgery) * Severe cardiovascular disease (e.g., myocardial infarction and unstable angina) that occurred within 24 weeks prior to baseline * New York Heart Association Class 3 or 4 heart failure within 24 weeks prior to baseline * Severe cerebrovascular disease observed within 24 weeks prior to baseline * Pulmonary thrombosis or deep vein thrombosis within 24 weeks prior to baseline, or bronchial asthma, obstructive pulmonary disease, or other serious, life-threatening lung disease (e.g., acute respiratory distress syndrome and lung failure) considered ineligible for study participation * Infections requiring treatment, such as systemic antibiotics and antivirals, within 2 weeks prior to baseline, or other uncontrolled ≥Grade 3 active infectious diseases * Symptomatic interstitial lung disease * Subjects who showed poor recovery from hematologic toxicity in the past chemotherapy (e.g., ≥grade 3 toxicity for ≥4 weeks) * Bone marrow or stem cell transplantation with high-dose chemotherapy * Total gastrectomy or total duodenectomy * Individuals with a history of myelodysplastic syndrome (MDS) or pretreatment cytogenetic test results indicating a risk of MDS/acute myeloid leukemia (AML) 4) Subjects with the following concurrent conditions: * Subjects with clinically significant symptoms or uncontrolled central nervous system or brain metastases (except when systemic corticosteroid administration was stopped at least 4 weeks prior to baseline and was stable for ≥4 weeks) * Subjects who have confirmed clinically significant conditions in the electrocardiogram (ECG) according to the investigator's judgment * Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg) * Bleeding diatheses * Active hepatitis B or C virus infection (patients with hepatitis may participate if HBV DNA and HCV RNA are below the lower limit of detection established by the study site) * Known human immunodeficiency virus infection (HIV) positive * Subjects with neurological and psychiatric disorders severe enough to affect the study results according to the investigator's judgment 5) Subjects who have the following drug treatment history: * Subjects who have received chemotherapy†, immunotherapy (including biologics), hormone therapy, or therapeutic/palliative radiotherapy‡ within 4 weeks prior to baseline * Subjects who require continuous (≥4 weeks) treatment of systemic corticosteroids equivalent to prednisone \>10 mg/day * Subjects who were treated with antithrombotic drugs, including antiplatelet agents and anticoagulants, within 2 weeks from baseline or are expected to be treated with them during the study period (however, low molecular weight heparin \[LMWH\]) treatment is allowed) * Subjects who require continuous administration of non-steroidal anti-inflammatory drugs (NSAIDs), which have high risk of bleeding 6) Pregnant or lactating women, or women of childbearing potential who do not intend to abstain or use appropriate contraceptive methods\* during the study period and up to 3 months after IP administration \*Appropriate contraception: 7) Subjects who have taken or undergone another IP or investigation device within 4 weeks prior to baseline 8) subjects who are judged by the investigator as ineligible for study participation
References
Publications (0)
Data not yet available
No reference posted for this study.