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

NCT ID: NCT05475184

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2025-06-30

Brief 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

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JPI-547

Group Type: EXPERIMENTAL

JPI-547

Intervention Type: DRUG

Poly-(ADP-ribose) polymerase (PARP) & tankyrase (TNKS) inhibitor.

• The investigational product (IP) will be administered once daily for 28 days (4 weeks) with 1 cycle.
• 1 capsule (JPI-547 150 mg) will be administered once daily at the same time (e.g., a fixed time in the morning) in a fasted condition within 2 hours before or after a meal.

Interventions

JPI-547

Poly-(ADP-ribose) polymerase (PARP) & tankyrase (TNKS) inhibitor.

• The investigational product (IP) will be administered once daily for 28 days (4 weeks) with 1 cycle.
• 1 capsule (JPI-547 150 mg) will be administered once daily at the same time (e.g., a fixed time in the morning) in a fasted condition within 2 hours before or after a meal.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Onconic Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center

Gyeonggi-do, , South Korea

Countries

South Korea

Other Identifiers

JPI-547-201

Identifier Type: -

Identifier Source: org_study_id