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Advanced Solid TumorsPhase 1NCT04335604

A Study of NOV140201 (JPI-547) in Subject With Advanced Solid Tumors

A Phase 1 study testing JPI-547 in people with Advanced Solid Tumors, run by Onconic Therapeutics Inc. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the Safety, Tolerability, and Pharmacokinetic-pharmacodynamic Profile and efficacy of JPI-547 in patients with advanced solid tumor. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
JPI-547
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesSouth Korea
Study dates
6 Dec 2017to 14 Dec 2021
Phase
Phase 1
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged 19 years old or above
  • Patients that are histologically or cytologically confirmed advanced solid tumors and are refractory to or are able to receive standard of care
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Individuals who volunteer to give to the written consent to the participation after listening to sufficient explanation for this clinical study

Who cannot join

  • History of severe drug hypersensitivity or hypersensitivity to IP or similar class
  • Patients who have the confirmed medical history or surgery/procedure history as the followings:
  • History of major surgery requiring general anesthesia or assisted respiration within 4 weeks prior to baseline (within 2 weeks for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery)
  • Severe cardiovascular disease (eg. myocardial infarction or unstable angina pectoris) within 24 weeks prior to baseline
  • New York Heart Association Class III or IV heart failure within 24 weeks prior to baseline
  • Severe cerebrovascular disease within 24 weeks prior to baseline
Show all 31Show fewer
  • Pulmonary artery thrombosis, deep vein thrombosis, or clinically severe pulmonary disease within 24 weeks prior to baseline
  • Infection requiring the administration of systemic antibiotics, antivirals or other uncontrolled Grade ≥3 Active infectious disease within 2 weeks prior to baseline
  • Symptomatic interstitial lung disease
  • Poor recovery from hematologic toxicities in previous anticancer treatment (eg. >4 weeks of Grade 3≥ toxicities)
  • Individuals who receive bone marrow or stem cell transplant with a high dose of chemotherapy
  • Individuals as accompanied by the following diseases:
  • Hematologic malignancy other than lymphoma
  • History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS/acute myelocytic leukemia (AML)
  • Patients with symptomatic with clinically significant or uncontrolled central nervous system (CNS) or brain metastasis (other than patients who discontinued the administration of systematic corticosteroid at least 4 weeks prior to baseline and who are radiologically and neurologically stable for ≥4 weeks)
  • Patients with clinically significant abnormalities in the judgment of the investigator according to electrocardiogram findings
  • Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic blood pressure >90mmHg)
  • Bleeding diatheses
  • History of active hepatitis B or C virus (hepatitis patients acceptable if HBV DNA and HCV RNA are <institutional lower limits)
  • positive known human immunodeficiency virus (HIV)infection
  • Severe neurological disorder and mental illness that may affect the study results in the opinion of the investigator
  • Individuals who have the following medication history:
  • Individuals with medication history of PARP inhibitors or TNK inhibitors (This applies only to Part 2.)
  • Individuals receiving chemotherapy, biological therapy, retinoid therapy, immunotherapy, hormone therapy or therapeutic/palliative radiotherapy for the treatment of advanced solid tumors within 4 weeks prior to baseline (except for the individuals who received nitrosourea or mitomycin within 6 weeks prior to baseline and biological target antibody within 6 weeks prior to baseline)
  • Patients requiring the continuous administration of non-steroidal anti-inflammatory drug (NSAID) with a high bleeding risk
  • Patients requiring continuous administration of systemic corticosteroid equivalent to Prednisone >10 mg/day
  • Individuals who received antithrombotics, including antiplatelets and anticoagulants within 2 weeks of baseline, or expecting to require the administration during the clinical study (the administration of low molecular weight heparin (LMWH) is allowed for the management and prevention of venous thrombosis during the clinical study.)
  • Individuals who start the new administration or dose change of bisphosphonate within 30 days of baseline among patients with breast cancer and prostatic cancer in a dose expansion cohort within 30 days of baseline (bisphosphonate administered stably for 30 days before baseline is allowed.)
  • Pregnant women, breastfeeding women, or female of childbearing potential and male who are not willing to practice abstinence or use appropriate contraception* during the clinical study and for 3 months after the administration of the IP
  • Individuals who were administered other IPs or the investigational device within 4 weeks prior to baseline
  • Individual considered ineligible or unavailable for this study for other reasons, in the opinion of the investigator

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University College of Medicine

    Seoul, 03080

Other trials in South Korea

About this study

Official title: An Open-label, Dose-finding, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetic-pharmacodynamic Profile of NOV140201 (JPI-547), a Dual Inhibitor of PARP/TNK in Patients With Advanced Solid Tumors

To assess the Safety, Tolerability, and Pharmacokinetic-pharmacodynamic Profile and efficacy of JPI-547 in patients with advanced solid tumor.

Read the detailed description

This is an open-label, Phase 1 dose escalation and expansion study of NOV140201 (JPI-547) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of JPI-547 in patients with advanced solid tumors after failure of standard of care.

Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.

Being tested
JPI-547

What participants receive

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

  • JPI-547Drug

    The dose levels will be escalated following a 3+3 dose escalation scheme.

Study groups in NCT04335604
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. Dose-limiting toxicity (DLT) and Maximum tolerated dose (MTD)

    subjects will be treated and observed for DLT through the end of the first cycle

    Measured: 21days

Secondary outcomes (5)

  1. Area under the plasma concentration versus time curve (AUC) of JPI-547

    to observe pharmacokinetic parameter

    Measured: 1 and 15 days

  2. Peak Plasma Concentration (Cmax) of JPI-547

    to observe pharmacokinetic parameter

    Measured: 1 and 15 days

  3. Time at maximum concentration(Tmax) of JPI-547

    to observe pharmacokinetic parameter

    Measured: 1 and 15 days

  4. Half-life of JPI-547

    to observe pharmacokinetic parameter

    Measured: 1 and 15 days

  5. Accumulation ratio of JPI-547

    to observe pharmacokinetic parameter

    Measured: 1 and 15 days

Timeline

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

  1. First posted6 Apr 2020
  2. Study start6 Dec 2017
  3. Primary completion14 Dec 2021
  4. Study completion14 Dec 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335604
Sponsor's protocol ID
NOV140201-101
Status last verified
Jun 2022
First submitted
31 Jan 2018
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JPI-547 in people with Advanced Solid Tumors, run by Onconic Therapeutics Inc. at 2 sites 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 5 inclusion and 31 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: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-limiting toxicity (DLT) and Maximum tolerated dose (MTD) (time frame: 21days). 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 NCT04335604.

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 3 Jun 2022.

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