Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462794
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
First In Human Study of CX-801 in Advanced Solid Tumors
Sponsor:
CytomX Therapeutics
Organization:
CytomX Therapeutics
Study Overview
Official Title:
An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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 first-in-human study CTMX-801-101 is to characterize the safety tolerability and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors
Detailed Description:
The study is comprised of 2 parts Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose MTD of CX-801 as monotherapy and as combination therapy CX-801 combined with pembrolizumab Part 2 dose expansion will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KEYNOTE-F95 | OTHER | None | None |
| MK-3475-F95 | OTHER | None | None |