Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03329950
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2017-10-23
Brief Title:
A Study of CDX-1140 CD40 as Monotherapy or in Combination in Patients With Advanced Malignancies
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This is a study to determine the maximum tolerated dose MTD for CDX-1140 CD40 antibody either alone or in combination with CDX-301 FLT3L pembrolizumab or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined
Detailed Description:
This study will determine the MTD of CDX-1140 while also evaluating the safety tolerability and efficacy of CDX-1140 alone Part 1 or in combination with CDX-301 Part 2 pembrolizumab Part 3 or chemotherapy Part 4 in patients with cancer
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140 The dose-escalation part of the study will test the safety profile of CDX-1140 alone or in combination with CDX-301 pembrolizumab or chemotherapy and determine which doses of CDX-1140 will be studied in the expansion portions of the study
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140 The dose-escalation part of the study will test the safety profile of CDX-1140 alone or in combination with CDX-301 pembrolizumab or chemotherapy and determine which doses of CDX-1140 will be studied in the expansion portions of the study
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur
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-A23 | OTHER | Merck | None |