Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05879822 | A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive | PHASE2 | ACTIVE NOT_RECRUITING | 73 | — | — | Oct 30, 2023 | Jul 22, 2026 | Dec 17, 2025 | 54 | Brazil, China +7 |
| NCT04242199 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors | PHASE1 | COMPLETED | 182 | — | — | Sep 4, 2020 | Nov 21, 2024 | Jul 14, 2025 | 21 | United States, Australia +3 |
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 | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |