Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05788484
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-03-15
Brief Title:
A Study of CDX-585 in Patients With Advanced Malignancies
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies
Status:
RECRUITING
Status Verified Date:
2024-06
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 an open-label non-randomized multicenter dose-escalation and expansion study in patients with selected solid tumors
Detailed Description:
This study will determine the maximum tolerated dose of CDX-585 while also evaluating the safety tolerability and efficacy of CDX-585 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-585 The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study
Approximately 130 patients will be enrolled 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
The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-585 The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study
Approximately 130 patients will be enrolled 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
The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study
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