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Ovarian CancerPhase 2NCT05475184

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

A Phase 2 study testing JPI-547 in people with Ovarian Cancer, run by Onconic Therapeutics Inc. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
JPI-547
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSouth Korea
Study dates
31 Aug 2022to Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Gyeonggi-do

Other trials in South Korea

About this study

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

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
Being tested
JPI-547
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JPI-547Drug

    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.
Study groups in NCT05475184
Study groupRoleWhat they receive
JPI-547ExperimentalNot described
Receives: Drug: JPI-547

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Anti-tumor activity

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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start31 Aug 2022
  3. Primary completionNov 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475184
Sponsor's protocol ID
JPI-547-201
Status last verified
Aug 2024
First submitted
13 Jul 2022
Last updated
27 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JPI-547 in people with Ovarian Cancer, run by Onconic Therapeutics Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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