Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05413421
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2022-06-07
Brief Title:
Study of ORIC-944 in Patients with Metastatic Prostate Cancer
Sponsor:
ORIC Pharmaceuticals
Organization:
ORIC Pharmaceuticals
Study Overview
Official Title:
An Open-Label Phase 11b Study of ORIC-944 As a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer
Detailed Description:
ORIC-944 is a potent highly selective allosteric orally bioavailable small molecule inhibitor of PRC2 via binding the embryonic ectoderm development EED subunit
This is a first-in-human open-label multicenter dose escalation study of ORIC-944 as a single agent Part I or in combination with an Androgen Receptor Pathway Inhibitor ARPI Part II to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combination with ARPIs in patients with metastatic prostate cancer Part III of the protocol dose optimization will explore two potential dose levels of ORIC-944 selected from Part II in combination with ARPIs to select the final RP2D for each combination across two separate patient populations
This is a first-in-human open-label multicenter dose escalation study of ORIC-944 as a single agent Part I or in combination with an Androgen Receptor Pathway Inhibitor ARPI Part II to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combination with ARPIs in patients with metastatic prostate cancer Part III of the protocol dose optimization will explore two potential dose levels of ORIC-944 selected from Part II in combination with ARPIs to select the final RP2D for each combination across two separate patient populations
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