A Phase I Study of LFA102 in Japanese Patients

Study Overview
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Brief Summary
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This study will evaluate safety and tolerability to determine the MTD/RD.

Detailed Description
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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.

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

Conditions
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Castration-resistant Prostate Cancer, Advanced Breast Cancer

Intervention / Treatment
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* Drug: LFA102


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFA102<br> | Drug: LFA102<br> <br> * Other names: anti prolactin receptor humanized monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicities (DLT) | Frequency and severity of dose limiting toxicities (DLTs) | 1st treatment cycle (28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency, duration and severity of Adverse Events (AEs) | Frequency, duration and severity of all AEs will be collected. | at informed consent, until 28 days after treatment discontinuation | 
| Serum Concentration |  | cycle 1 day 1 until disease progression | 
| Objective Response Rate | Assessed based on RECIST/PCWG2 criteria | every 8 week or 12 weeks, until disase progression | 
| Antibodies against LFA102 | Serum concentration of antibodies against LFA102 | day 1 of each treatment cycle until disease progression | 
| Progression Free Survival | Assessed based on RECIST/PCWG2 criteria | every 8 or 12 weeks until disease progression | 
| PK parameters | Cmax, Tmax, AUC, T1/2, CL and V | cycle 1 day 1 until disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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castration-resistant prostate cancer, advanced breast cancer