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

NCT05475184 | Active Not Recruiting Phase 2

• 1 other identifier: JPI-547-201
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  To evaluate the objective response rate (ORR) in accordance with the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

  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

Secondary Outcomes (1)

• Anti-tumor activity

  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

Study Arms (1)

JPI-547

EXPERIMENTAL

Drug: JPI-547

Interventions

JPI-547 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.

JPI-547

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced/metastatic high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer\*:
• who has undergone ≥2 previous chemotherapy regimen;
• with confirmed platinum resistance\*\*;
• ≥3 month PARP inhibitor treatment history;
• 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

You may not qualify if:

• Subjects who meet any of the following conditions cannot participate in this study:
• Subjects with a history of severe drug hypersensitivity or the hypersensitivity to IP and its ingredients or similar drugs
• Subjects with dysphagia
• 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

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

National Cancer Center

Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be conducted with subjects with HRD-positive, platinum-resistant, advanced/relapsed ovarian cancer with a history of ARP inhibitor treatment using Simon's optimal two-stage design. When the confirmed response is observed in ≥3 out of 18 subjects who are available for tumor assessment in Stage 1, the subjects will proceed with Stage 2. After additional enrollment of 40 subjects who are available for tumor assessment in Stage 2, the assessment will be conducted to identify that the confirmed response is observed in ≥11 out of the final 58 subjects.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 26, 2022
• Study Start: August 31, 2022
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

KR (1)