Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DKY709 · 1 trial · 5 indications
Incidence and severity of AEs and SAEs
The incidence of DLTs during the first cycle of treatment with single agent DKY709 or the combination of DKY709 with PDR001.
Incidence and severity of AEs and SAEs
| Arm | Type | Description |
|---|---|---|
| DKY709 | EXPERIMENTAL | DKY709 monotherapy |
| DKY709 + PDR001 | EXPERIMENTAL | Combination therapy with DKY709 and PDR001 |
| Name | Type | Description |
|---|---|---|
| DKY709 | DRUG | Novel immunomodulatory agent |
| PDR001 | DRUG | PDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2 |
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...
DKY709 is an investigational small molecule being studied in adults with advanced solid tumors, including non-small-cell lung carcinoma, melanoma, nasopharyngeal carcinoma, microsatellite stable colorectal cancer, and triple negative breast cancer. It is not yet approved for any indication and remains in clinical development.
DKY709 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the compound in advanced solid tumors.
DKY709 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for commercial use.
DKY709 is being evaluated in a single Phase 1 trial, NCT03891953, titled a study of safety and efficacy of DKY709 alone or in combination with PDR001 in patients with advanced solid tumors. The trial is active but not recruiting, with an enrollment of 98 patients across the United States, Germany, Hong Kong, Japan, Spain, and Taiwan.
Yes, the DKY709 Phase 1 trial NCT03891953 is biomarker selected, meaning enrollment is guided by specific biomarker criteria. The study is controlled and enrolls adults aged 18 years and older with advanced solid tumors.