This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Novartis Investigative Site
Dresden, Saxony, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Taipei, Taiwan
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.
Incidence and severity of AEs and SAEs
Time frame: 24 months
incidence of Dose Limiting Toxicities (DLTs)
The incidence of DLTs during the first cycle of treatment with single agent DKY709 or the combination of DKY709 with PDR001.
Time frame: 1 Month
Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.
Incidence and severity of AEs and SAEs
Time frame: 24 months
AUC of DKY709 and PDR001
AUC
Time frame: 24 months
Cmax of DKY709 and PDR001
Cmax
Time frame: 24 months
Tmax of DKY709 and PDR001
Tmax
Time frame: 24 months
Half-life of DKY709 and PDR001
Half-life
Time frame: 24 months
Progression Free Survival (PFS)
Determine PFS in each part of the study
Time frame: 24 months
Best Overall Response (BOR)
Determine BOR in each part of the study
Time frame: 24 months
Duration of Response (DOR)
Determine DOR in each part of the study
Time frame: 24 months
Time to Progression (TTP)
Determine TTP in each part of the study
Time frame: 24 months
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