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    DRUG:

    INCB99280

    i
    Other names: INCB99280, INCB099280
    Associations

    News

    Trials
    Company:
    Incyte
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=5, Terminated, Incyte Corporation | Trial completion date: Dec 2027 --> Jun 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Jun 2025; This was a strategic business decision. There were no safety concerns contributing to this decision.
    Trial completion date • Trial termination • Trial primary completion date
    |
    Inlyta (axitinib) • INCB99280
    4ms
    A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation (clinicaltrials.gov)
    P1, N=6, Terminated, Incyte Corporation | Trial completion date: Nov 2025 --> Jul 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Apr 2025; This was a strategic business decision. There were no safety concerns contributing to this decision.
    Trial completion date • Trial termination • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability)
    |
    KRAS mutation • MSI-H/dMMR • KRAS G12C • RAS wild-type • KRAS G12
    |
    Krazati (adagrasib) • INCB99280
    10ms
    Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors (clinicaltrials.gov)
    P1, N=8, Terminated, Incyte Corporation | Trial completion date: Jul 2026 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Sep 2024; This was a strategic business decision. There were no safety concerns contributing to this decision.
    Trial completion date • Trial termination • Trial primary completion date
    |
    MSI (Microsatellite instability) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Yervoy (ipilimumab) • INCB99280
    10ms
    A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive (clinicaltrials.gov)
    P2, N=73, Active, not recruiting, Incyte Corporation | Trial completion date: Jan 2027 --> Jul 2026 | Trial primary completion date: Jan 2027 --> Jul 2026
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    INCB99280
    10ms
    The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB099280 in healthy adult participants, and the effect of food on pharmacokinetics (ACTRN12619001529134)
    P1, N=72, Completed, Incyte Corporation | Not yet recruiting --> Completed
    Trial completion
    |
    INCB99280
    11ms
    NETOS: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=182, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    INCB99280
    1year
    NETOS: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=182, Active, not recruiting, Incyte Corporation | Trial completion date: Oct 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    INCB99280
    over1year
    Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P1, N=0, Withdrawn, Abramson Cancer Center at Penn Medicine | N=15 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Pre-transplantation
    |
    INCB99280
    over1year
    A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | N=314 --> 73
    Checkpoint inhibition • Enrollment change • Enrollment closed
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    INCB99280
    over1year
    A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=240 --> 63
    Enrollment closed • Enrollment change • Metastases
    |
    INCB99280
    over1year
    NETOS: A personalized approach of neoadjuvant therapy, including INCB099280 monotherapy and bladder preservation, for muscle-invasive urothelial bladder carcinoma (MIBC) with ctDNA monitoring (ESMO 2024)
    Our hypothesis is that INCB099280 can be offered in selected pts as an induction and maintenance therapy instead of RC in pts who achieve a cCR.Trial design: Pts should have a predominant urotelial carcinoma (UC) histology, have a clinical stage T2-T4N0M0 MIBC, be ineligible for or refuse to receive cisplatin-based chemotherapy. The overall sample size Will be of 30 pts. Secondary endpoints will include safety (CTCAE v.5.0), event-free survival, bladder-intact overall survival (OS) and OS (EUCT number: 2024-511029-73-00).
    Clinical • Circulating tumor DNA
    |
    Signatera™
    |
    cisplatin • INCB99280
    over1year
    Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=100 --> 8
    Enrollment closed • Enrollment change • Combination therapy
    |
    MSI (Microsatellite instability) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2 (Interleukin 2)
    |
    Yervoy (ipilimumab) • INCB99280