NCT04335604

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

January 31, 2018

Last Update Submit

June 1, 2022

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (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

    21days

Secondary Outcomes (5)

  • 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

Study Arms (1)

JPI-547

EXPERIMENTAL
Drug: JPI-547

Interventions

JPI-547DRUG

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

JPI-547

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University College of Medicine

Seoul, 03080, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

April 6, 2020

Study Start

December 6, 2017

Primary Completion

December 14, 2021

Study Completion

December 14, 2021

Last Updated

June 3, 2022

Record last verified: 2022-06

Locations

KR(2)