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

Conditions: Ovarian Cancer

Summary: 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


Eligibility criteria:
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