The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas. This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules. The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas. Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Incidence of Dose Limiting Toxicities (DLTs) - Single Agent
Dose Limiting Toxicities
Time frame: 21 days
Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents
Dose Limiting Toxicities
Time frame: 42 days
Best Overall Response (BOR),
Time frame: 36 months
Progression Free Survival (PFS)
per irRC and RECIST v1.1 or Cheson (2014)
Time frame: 36 months
Serum concentration profiles of GWN323 as a single agent: Cmax
Time frame: 36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax
Time frame: 36 months
Presence and titer of anti-GWN323 antibodies
Time frame: 36 months
Measurement of the effector/regulatory T cell ratio
Time frame: at screening, 36 months
Serum concentration profiles of GWN323 as a single agent: AUC
Time frame: 36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC
Time frame: 36 months
Presence and titer of anti-PDR001 antibodies
Time frame: 36 months
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