Trials / Completed
CompletedNCT04335604
A Study of NOV140201 (JPI-547) in Subject With Advanced Solid Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Onconic Therapeutics Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JPI-547 | The dose levels will be escalated following a 3+3 dose escalation scheme. |
Timeline
- Start date
- 2017-12-06
- Primary completion
- 2021-12-14
- Completion
- 2021-12-14
- First posted
- 2020-04-06
- Last updated
- 2022-06-03
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04335604. Inclusion in this directory is not an endorsement.