Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01460134
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2011-10-12
Brief Title:
A Study of CDX-1127 Varlilumab in Patients With Select Solid Tumor Types or Hematologic Cancers
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase 1 Open-label Dose-escalation Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-08
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 of CDX-1127 a therapy that targets the immune system and may act to promote anti-cancer effects The study enrolls patients with hematologic cancers certain leukemias and lymphomas as well as patients with select types of solid tumors
Detailed Description:
CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and also on certain hematologic tumor cells and may act to promote anti-tumor effects
This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell and T-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system
Eligible patients who enroll in the dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127 This first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies
During the Expansion phase cohorts of approximately 15 patients each will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer Expansion cohorts may be limited to one or more tumor types
Patients enrolled in the study may receive study treatment for up to 5 cycles until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons
All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur
This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell and T-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system
Eligible patients who enroll in the dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127 This first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies
During the Expansion phase cohorts of approximately 15 patients each will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer Expansion cohorts may be limited to one or more tumor types
Patients enrolled in the study may receive study treatment for up to 5 cycles until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons
All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None