Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB099280 · 4 trials · 13 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.
Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.
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. |
| INCB099280 | EXPERIMENTAL | Participants will be administered INCB099280 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280. |
| 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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
INCB099280 is an investigational small molecule being studied for the treatment of advanced solid tumors and cutaneous squamous cell carcinoma. It is also being evaluated in healthy participants for pharmacokinetic studies. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
INCB099280 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. Incyte is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.
INCB099280 is currently in Phase 2 clinical development. It has completed a Phase 1 trial in advanced solid tumors and has active Phase 2 trials in advanced solid tumors and cutaneous squamous cell carcinoma. The drug remains investigational and has not received FDA approval.
INCB099280 has been studied in several clinical trials. NCT04242199 was a completed Phase 1 trial in advanced solid tumors. NCT05879822 is an active Phase 2 trial in immune checkpoint inhibitor naive patients with advanced solid tumors. NCT05888844 is an active Phase 2 trial in cutaneous squamous cell carcinoma. NCT06309394 was a completed Phase 1 mass balance study in healthy participants.
INCB099280 is the sole identifier for this investigational drug. No alternative names or brand names have been associated with this compound in the clinical trial data. It is being developed by Incyte Corporation as a unique small molecule oncology candidate.
The mechanism of action for INCB099280 has not been disclosed in the available clinical trial information. It is being studied as a small molecule therapeutic for advanced solid tumors and cutaneous squamous cell carcinoma, but its specific molecular target has not been publicly detailed.