Recent Updates
Recently added Catalysts

DKY709

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

DKY709 · 1 trial · 5 indications

Phase 1 1
NCT03891953Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.Carcinoma, Non-Small-Cell Lung
ACTIVE NOT_RECRUITING98 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
Carcinoma, Non-Small-Cell LungUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about DKY709

What is DKY709 used for?

DKY709 is an investigational small molecule being studied for the treatment of advanced solid tumors, including carcinoma, non-small-cell lung cancer, melanoma, nasopharyngeal carcinoma, microsatellite stable colorectal cancer, and triple negative breast cancer. It is currently in Phase 1 clinical development.

What does DKY709 target?

DKY709 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its potential anti-tumor activity in advanced solid tumors, both as a single agent and in combination with PDR001.

Who is developing DKY709?

DKY709 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is DKY709 in?

DKY709 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with advanced solid tumors.

What clinical trials is DKY709 in?

DKY709 is being studied in a Phase 1 clinical trial with the identifier NCT03891953. This trial evaluates the safety and efficacy of DKY709 alone or in combination with PDR001 in patients with advanced solid tumors, including non-small-cell lung cancer, melanoma, and other cancers.

Is DKY709 the same as PDR001?

No, DKY709 is not the same as PDR001. DKY709 is an investigational small molecule being studied as a single agent and in combination with PDR001, which is a separate investigational drug. The combination is being evaluated in a Phase 1 clinical trial for advanced solid tumors.