Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers
Brief Summary: The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated patients with advanced epithelial cancer.The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan. This is planned as a multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up to 50 patients (assessable) per other cancer types included in the protocol will be studied at the 10 mg/kg dose.