Phase I Study of PDR001 in Patients With Advanced Malignancies.

Study Overview
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Brief Summary
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The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.

Official Title
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A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies

Conditions
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Advanced Malignancies

Intervention / Treatment
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* Drug: PDR001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists ECOG Performance Status ≤ 2 Exclusion Criteria: Active autoimmune disease Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Prior PD-1- or PD-L1-directed therapy Other protocol defined inclusion/exclusion 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: PDR001<br>PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established. | Drug: PDR001<br>* PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting toxicities (DLTs) | cycle = 28 days | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter: AUC | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | 
| Serum concentration vs. time profiles | Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration | C1D1, C3D1 | 
| Presence and/or concentration of anti-PDR001 antibodies | To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001. | Day 1 on from C1 to C6 | 
| Objective response rate (ORR) | cycle = 28 days | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) | 
| Duration of response rate (DOR) | cycle = 28 days | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) | 
| Disease control rate (DCR) | cycle = 28 days | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) | 
| PK parameter: Cmax | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | 
| PK parameter: Tmax | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | 
| PK parameter: half-life | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced malignancies, PDR001, Japanese patients, adults