A First in Man Study of MABp1 in Patients With Advanced Cancers
The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process.
An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of MABp1 in Patients With Advanced Cancers|
- Maximum tolerated dose [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Tumor response [ Time Frame: one year ] [ Designated as safety issue: No ]
- Cachexia Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change in LBT as measured by DEXA
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
The study will utilize a standard 3+3 design for dose escalation. Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored.
0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.