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

Onconic Therapeutics Inc.2 sites in 1 country62 target enrollmentDecember 6, 2017

ConditionsAdvanced Solid Tumors

InterventionsJPI-547

DrugsJPI-547

Overview

Phase: Phase 1
Intervention: JPI-547
Conditions: Advanced Solid Tumors
Sponsor: Onconic Therapeutics Inc.
Enrollment: 62
Locations: 2
Primary Endpoint: Dose-limiting toxicity (DLT) and Maximum tolerated dose (MTD)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

December 6, 2017

End Date

December 14, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Onconic Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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
•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)

Arms & Interventions

JPI-547

Intervention: JPI-547

Outcomes

Primary Outcomes

Dose-limiting toxicity (DLT) and Maximum tolerated dose (MTD)

Time Frame: 21days

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

Secondary Outcomes

Area under the plasma concentration versus time curve (AUC) of JPI-547(1 and 15 days)
Peak Plasma Concentration (Cmax) of JPI-547(1 and 15 days)
Time at maximum concentration(Tmax) of JPI-547(1 and 15 days)
Half-life of JPI-547(1 and 15 days)
Accumulation ratio of JPI-547(1 and 15 days)