Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-03-01 @ 12:17 AM
Study NCT ID:
NCT03525795
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2018-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ORIOn-E: A Study Evaluating CPI-1205 in Patients With Advanced Solid Tumors
Sponsor:
Constellation Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1 Study of CPI-1205 With Ipilimumab in Patients With Advanced Solid Tumors Followed by a Phase 2 Basket Study of CPI-1205 With Ipilimumab in Selected Tumor Types Previously Treated With PD-1 or PD-L1 Inhibitors
Status:
COMPLETED
Status Verified Date:
2022-05
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:
This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the RP2D of CPI-1205 + ipilimumab.
This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.
This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.
Detailed Description:
None
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?: