Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB099280 · 3 trials · 12 indications
Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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 the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.
Number of participants with TEAEs leading to dose modification or discontinuation.
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 30 days after last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Part 1: INCB099280 Dose 1 | EXPERIMENTAL | Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years. |
| Part 1: INCB099280 Dose 2 | EXPERIMENTAL | Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. |
| Part 1: INCB099280 Dose 3 | EXPERIMENTAL | Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years |
| Part 2: INCB099280 Dose selected from Part 1 | EXPERIMENTAL | Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years. |
| Cohort 1 | EXPERIMENTAL | Participants with select solid tumors who are immunotherapy treatment-naive |
| Cohort 2 | EXPERIMENTAL | Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. |
| Cohort 3 | EXPERIMENTAL | Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy |
| Name | Type | Description |
|---|---|---|
| INCB099280 | DRUG | Administered as specified in the treatment arm description |
Inclusion Criteria: * Immunotherapy naive and without access to approved and/or available immune checkpoint inhibitor (ICI) therapy. * Measurable disease per RECIST v1.1. * One of the following disease settings: * Unresectable or metastatic Child-Pugh Class A hepatocellular carcinoma (HCC) not e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
INCB099280 is an investigational small molecule being studied in oncology for advanced solid tumors and cutaneous squamous cell carcinoma. It is in Phase 2 clinical development by Incyte Corporation and is not yet approved for any indication. Trials enroll adults aged 18 and older.
INCB099280 is in Phase 2 clinical development. Two Phase 2 trials are ongoing, one in advanced cutaneous squamous cell carcinoma and one in select solid tumors in immune checkpoint inhibitor naive participants. A Phase 1 study has been completed. The drug remains investigational and has not been approved by the FDA.
INCB099280 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical program evaluating the drug in advanced solid tumors and cutaneous squamous cell carcinoma.
INCB099280 has been studied in three registered trials. NCT05888844 is a Phase 2 study in advanced cutaneous squamous cell carcinoma, and NCT05879822 is a Phase 2 study in select solid tumors in immune checkpoint inhibitor naive participants. NCT04242199, a completed Phase 1 study, evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in advanced solid tumors.
Across the three registered studies, 318 participants have been enrolled. The completed Phase 1 trial NCT04242199 enrolled 182 participants, the Phase 2 trial NCT05888844 enrolled 63, and the Phase 2 trial NCT05879822 enrolled 73. All trials enrolled adults aged 18 years and older.
Yes, INCB099280 trials include biomarker-selected populations. The completed Phase 1 study NCT04242199 enrolled participants with tumor types including MSI-H/dMMR tumors and PD-L1 amplified tumor with 9p24.1 amplification, alongside other advanced solid tumors. The Phase 2 program includes a controlled, randomized design.