A Phase I Study of LFA102 in Japanese Patients

• Dose Limiting Toxicities (DLT) [ Time Frame: 1st treatment cycle (28 days) ] [ Designated as safety issue: Yes ]
  Frequency and severity of dose limiting toxicities (DLTs)
  
  

• Frequency, duration and severity of Adverse Events (AEs) [ Time Frame: at informed consent, until 28 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
  Frequency, duration and severity of all AEs will be collected.
  
  
• Serum Concentration [ Time Frame: cycle 1 day 1 until disease progression ] [ Designated as safety issue: No ]
  
• Objective Response Rate [ Time Frame: every 8 week or 12 weeks, until disase progression ] [ Designated as safety issue: No ]
  Assessed based on RECIST/PCWG2 criteria
  
  
• Antibodies against LFA102 [ Time Frame: day 1 of each treatment cycle until disease progression ] [ Designated as safety issue: No ]
  Serum concentration of antibodies against LFA102
  
  
• Progression Free Survival [ Time Frame: every 8 or 12 weeks until disease progression ] [ Designated as safety issue: No ]
  Assessed based on RECIST/PCWG2 criteria
  
  
• PK parameters [ Time Frame: cycle 1 day 1 until disease progression ] [ Designated as safety issue: No ]
  Cmax, Tmax, AUC, T1/2, CL and V
  
  

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.