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

July 24, 2022 updated by: Onconic Therapeutics Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: JPI-547
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate(ORR)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumor activity
Time Frame: 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
To evaluate the anti-tumor activity in accordance with RECIST v1.1.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onconic Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2022

Primary Completion (ANTICIPATED)

November 1, 2024

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (ACTUAL)

July 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPI-547-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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