Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT03715504
Brief Summary:
TP-3654 is an oral PIM inhibitor. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors.
Detailed Description:
Primary Objective:
• To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors.
Secondary Objectives:
* To establish the pharmacokinetic (PK) profile of orally administered TP-3654
* To observe patients for any evidence of antitumor activity of TP-3654 by objective radiographic assessment
* To study the pharmacodynamic effects of TP-3654 therapy
* To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-3654
Study:
NCT03715504
Study Brief:
Protocol Section:
NCT03715504