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

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

Key Facts

Interventions

Conditions

Eligibility

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

Outcome Measures

Locations