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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

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
JPI-547
Sponsored by
Onconic Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    JPI-547

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Anti-tumor activity
    To evaluate the anti-tumor activity in accordance with RECIST v1.1.

    Full Information

    First Posted
    July 13, 2022
    Last Updated
    July 24, 2022
    Sponsor
    Onconic Therapeutics Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05475184
    Brief Title
    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
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Onconic Therapeutics Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    58 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    JPI-547
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    JPI-547
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Objective Response Rate(ORR)
    Description
    To evaluate the objective response rate (ORR) in accordance with the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
    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
    Secondary Outcome Measure Information:
    Title
    Anti-tumor activity
    Description
    To evaluate the anti-tumor activity in accordance with RECIST v1.1.
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Onconictherapeutics
    Phone
    02-3454-0780
    Email
    onconictherapeutics@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    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

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