Ph I Dose Escalation Study of Antibody-drug Conjugate IMMU-132 in Patients With Advanced Epithelial Cancers
The purpose of this study is to test the safety of IMMU-132 at different dose levels. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers and is also known as EGP-1 (epithelial glycoprotein-1). The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan (CPT-11).
Advanced Epithelial Cancers
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer|
- Safety [ Time Frame: during treatment and the change at the final evaluation after treatment ] [ Designated as safety issue: Yes ]Safety will be assessed by monitoring the patient for adverse events, monitoring the change in lab values during and after treatment compared to baseline over an average of 6 months.
- Efficacy [ Time Frame: Efficacy will be assessed at 6-8 weeks during treatment and at the end of treatment ] [ Designated as safety issue: No ]Efficacy will be assessed by measuring the change in tumor measurements based on CT scan changes from baseline to 6-8 weeks during treatment and the changes from these 2 timepoints until the end of treatment, over an average of 6 months.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
IMMU-132 is an antibody drug conjugate where the antibody, RS7 is attached to SN38. SN38 is the active metabolit of irinotecan (CPT-11).
IMMU-132 is an antibody-drug conjugate which will be administered on days 1 & 8 of 3 week treatment cycles. Up to 8 cycles will be given.
IMMU-132 will be administered on days 1 & 8 of a 21-day treatment cycle and up to 8 cycles may be administered. Treatment will continue until unacceptable toxicity or progression of disease. Both safety and efficacy will be assessed.
|Contact: Anne Johnson, RNfirstname.lastname@example.org|
|Contact: Fran Bozza||973-605-8200|
|United States, Delaware|
|Helen F. Graham Cancer Center||Recruiting|
|Newark, Delaware, United States, 19713|
|Contact: Kathy Combs, RN email@example.com|
|Principal Investigator: Michael Guarino, MD|
|United States, Florida|
|MD Anderson Cancer Center Orlando||Not yet recruiting|
|Orlando, Florida, United States, 32806|
|United States, Indiana|
|IU Health Goshen Cancer Center||Recruiting|
|Goshen, Indiana, United States, 46526|
|Contact: Tracy Thorne, RN firstname.lastname@example.org|
|Principal Investigator: Alexander Starodub, MD|
|United States, New York|
|Weill Cornell/New York Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10021|
|Contact: Romae Palmer 646-962-9349 email@example.com|
|Principal Investigator: Allyson Ocean, MD|
|United States, Washington|
|Virginia Mason Cancer Center||Not yet recruiting|
|Seattle, Washington, United States, 98111|
|Principal Investigator: Vincent Picozzi, MD|
|Study Chair:||William Wegener, MD, PhD||Immunomedics, Inc.|