Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01561911
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2012-03-21
Brief Title:
A Phase I Study of the Chimeric Anti-CD40 Monoclonal Antibody ChiLob 74 to Treat Advanced Malignancies Refractory to Conventional Anti-cancer Treatment
Sponsor:
Cancer Research UK
Organization:
Cancer Research UK
Study Overview
Official Title:
A Phase I Clinical Research Study Evaluating the Safety Tolerability and Biological Effects of the Chimeric Anti-CD40 Monoclonal Antibody Chi Lob 74 Given Intravenously Weekly for Four Weeks in the Treatment of Patients With Advanced Malignancies Refractory to Conventional Anti-cancer Treatment
Status:
COMPLETED
Status Verified Date:
2014-12
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 study is to evaluate the safety and tolerability and the biological effects of the chimeric anti-CD40 monoclonal antibody Chi Lob 74 given intravenously weekly for 4 weeks in the treatment of patients with advanced malignancies refractory to conventional anti-cancer treatment
Detailed Description:
The primary objective of the study is to establish the safety and maximum tolerated dose of Chi Lob 74 In line with other established antineoplastic chimeric monoclonal antibody therapies such as Rituximab Chi Lob 74 will be given by slow intravenous infusion once every week for a total of four weeks This treatment regimen will facilitate early rapid and dose dense administration of antibody to a patient group with advanced malignancy refractory to conventional treatment The starting dose for each infusion of Chi Lob 74 will be 05mg giving a total dose per patient of 2mg divided over 4 weeks Escalation from one treatment dose level to another will only be permitted when at least 3 patients have completed treatment without dose limiting toxicity
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