NCT01021072

A First in Man Study of MABp1 in Patients With Advanced Cancers

A Phase 1 Study of MABp1 in Patients With Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Cancers

Interventions

Type	Name	Description
DRUG	MABp1	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.

Timeline

• Start date: 2010-03-31
• Primary completion: 2012-10-31
• Completion: 2013-08-31
• First posted: 2009-11-26
• Last updated: 2021-02-16

Locations

2 sites across 1 country: United States