Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT03715504
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2018-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TP-3654 in Patients With Advanced Solid Tumors
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
• 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: