A Phase I Study of LFA102 in Japanese Patients

A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer

This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure. This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.

Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer Histologically or cytologically confirmed locally advanced or metastatic breast cancer Exclusion Criteria: Patients with untreated and/or symptomatic metastatic CNS disease Prior anaphylactic or other severe infusion reaction Treatment with agent which affect prolactin levels Active autoimmune disease Other protcol-defined Inclusion/Exclusion criteria may apply.