Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136884
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-07
Brief Title:
A First-In-Human Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor AO-252 in Advanced Solid Tumors
Sponsor:
A2A Pharmaceuticals Inc
Organization:
A2A Pharmaceuticals Inc
Study Overview
Official Title:
A First-In-Human Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor AO-252 in Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study is to assess the safety tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies
Detailed Description:
The purpose of this study is to characterize the safety tolerability including determination of maximum tolerated dose MTD and identify the recommended Phase 2 dose RP2D The study will also look at pharmacokinetics PK pharmacodynamics PD and preliminary anti-tumor activity of AO-252 as a monotherapy in participants with advanced or metastatic triple negative breast cancer TNBC high- grade serous ovarian carcinoma HGSOC and endometrial cancer
Study Oversight
Has Oversight DMC:
None
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?:
None