Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB106385 · 1 trial · 11 indications
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A (TGA) - INCB106385 | EXPERIMENTAL | In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE. |
| Treatment Group B (TGB) - INCB106385+INCMGA00012 | EXPERIMENTAL | In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE. |
| Name | Type | Description |
|---|---|---|
| INCB106385 | DRUG | INCB106385 will be administered orally QD |
| INCMGA00012 | DRUG | INCMGA0012 will be administered IV once every 4 weeks (Q4W) |
Inclusion Criteria: * Ability to comprehend and willingness to sign an ICF. * Willing and able to conform to and comply with all Protocol requirements. * Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignan...
Top 20 of 60 competitors
INCB106385 is an investigational small molecule developed by Incyte Corporation for the treatment of advanced solid tumors, including ovarian cancer. It is being studied as a single agent and in combination with immunotherapy. It remains in clinical development and is not approved for any indication.
INCB106385 targets the A2A and A2B adenosine receptors, a class of cell surface receptors. By acting on these adenosine receptors, the drug is designed to modulate adenosine-mediated signaling in the tumor microenvironment. This receptor-targeted mechanism is being evaluated in advanced solid tumors.
INCB106385 is developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical program evaluating the compound in advanced solid tumors, including ovarian cancer and several other tumor types.
INCB106385 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program has been completed, and the drug remains in early-stage clinical evaluation.
INCB106385 has been studied in one Phase 1 trial, NCT04580485, titled INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors. The trial enrolled 54 participants across the United States, Belgium, France, Italy, Spain, and the United Kingdom, and it is now completed.
INCB106385 is being evaluated for the treatment of ovarian cancer as part of a Phase 1 study in advanced solid tumors. The trial also enrolled patients with bladder cancer, non small cell lung cancer, head and neck squamous cell carcinoma, triple negative breast cancer, and other tumor types. It is not approved for ovarian cancer.