Advanced Malignancies
Conditions
Keywords
Advanced malignancies, PDR001, Japanese patients, adults
Brief summary
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.
Interventions
DRUGPDR001
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.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | 28 days | cycle = 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration vs. time profiles | C1D1, C3D1 | Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration |
| Presence and/or concentration of anti-PDR001 antibodies | Day 1 on from C1 to C6 | To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001. |
| Objective response rate (ORR) | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) | cycle = 28 days |
| Duration of response rate (DOR) | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) | cycle = 28 days |
| PK parameter: AUC | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | To characterize the PK profile of PDR001; cycle = 28 days |
| PK parameter: Cmax | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | To characterize the PK profile of PDR001; cycle = 28 days |
| PK parameter: Tmax | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | To characterize the PK profile of PDR001; cycle = 28 days |
| PK parameter: half-life | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) | To characterize the PK profile of PDR001; cycle = 28 days |
| Disease control rate (DCR) | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) | cycle = 28 days |
Countries
Japan
Outcome results
None listed