Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03429218
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First-in-human Study of Oral TP-0184 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-0184 Administered Once Weekly for 4 Weeks to 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-0184 is a potent inhibitor of ALK2 or ACRV1 kinase, a constitutively active serine/threonine receptor kinase due to activating mutations or upregulated upstream signaling pathways. 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-0184 administered once weekly for 4 weeks 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-0184 administered once weekly for 4 weeks, over a range of doses in patients with advanced solid tumors.
Secondary Objectives:
* To establish the pharmacokinetics of orally administered TP-0184
* To observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment
* To study the pharmacodynamics of TP-0184 therapy
* To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0184
• To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0184 administered once weekly for 4 weeks, over a range of doses in patients with advanced solid tumors.
Secondary Objectives:
* To establish the pharmacokinetics of orally administered TP-0184
* To observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment
* To study the pharmacodynamics of TP-0184 therapy
* To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0184
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?: