Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers

Investigator: Jenny Chang, MD

Study Coordinator: Maria Salazar

Status: Enrolling

ClinicalTrials.gov Number: NCT01631552

Phone: 713.441.6011

IRB Number: Pro00012572

Description

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. 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. Depending on toxicity, 3-6 patients per dose cohort may be enrolled in up to 4 planned dose levels during Phase I dose escalation, for a maximum total enrollment of 24 patients. In Phase II, up to 50 evaluable patients per select cancer types will be studied at up to 2 dose levels at or below the maximum acceptable dose determined in Phase I.
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