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Clinical Trial 18391
Cancer Type: Thoracic
Study Type: Treatment
Phase of Study: Phase II
A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients with Epithelial Cancer
The purpose of this study is to test the safety of IMMU-132 at different dose levels. Investigators want to find out what effects, good and/or bad, it has on participants and their advanced epithelial cancer.
Primary Objective: 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. Dose escalation in Phase I (completed) was intended to determine a maximum acceptable dose and select cancer types for continued expanded study in Phase II. Phase II continues enrollment with dose levels and cancers selected based upon Phase I results. Secondary Objectives: The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen.