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DKY709

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Novartis AG|Last Updated: Jan 21, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment98
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03891953Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.PHASE1 ACTIVE NOT_RECRUITING 98May 7, 2019Oct 31, 2026Jan 21, 20269 United States, Germany +4
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Study Endpoints
Primary Endpoints
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.
24 months

Incidence and severity of AEs and SAEs

incidence of Dose Limiting Toxicities (DLTs)
1 Month

The incidence of DLTs during the first cycle of treatment with single agent DKY709 or the combination of DKY709 with PDR001.

Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.
24 months

Incidence and severity of AEs and SAEs

Secondary Endpoints
AUC of DKY709 and PDR001
24 months
Cmax of DKY709 and PDR001
24 months
Tmax of DKY709 and PDR001
24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DKY709EXPERIMENTALDKY709 monotherapy
DKY709 + PDR001EXPERIMENTALCombination therapy with DKY709 and PDR001
Interventions
NameTypeDescription
DKY709DRUGNovel immunomodulatory agent
PDR001DRUGPDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Patients must be ≥18 years of age at the time of informed consent form (ICF) signature. 3. Patients with advanced/metastatic cancer who have progressed despite having received standard therapy in...

Countries:United StatesGermanyHong KongJapanSpainTaiwan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03891953primaryCompletionDate: changed
LOWMay 24, 2026NCT03891953studyFirstPostDate: changed