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A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers

Phase I Primary: In Phase I, the primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles, in previously treated patients with advanced epithelial cancer. Phase I Secondary: The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. Phase II Primary: In phase II, the primary objective is the evaluation of the safety and efficacy of IMMU-132 administered in 3-week treatment cycles at a dose selected in Phase I. Phase II Secondary: The secondary objectives include pharmacokinetics and immunogenicity.

Phase I Primary: In Phase I, the primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles, in previously treated patients with advanced epithelial cancer. Phase I Secondary: The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. Phase II Primary: In phase II, the primary objective is the evaluation of the safety and efficacy of IMMU-132 administered in 3-week treatment cycles at a dose selected in Phase I. Phase II Secondary: The secondary objectives include pharmacokinetics and immunogenicity.