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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
    23d
    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
    4ms
    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    P1, N=0, Withdrawn, Abramson Cancer Center at Penn Medicine | N=15 --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 Withdrawn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
    4ms
    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
    4ms
    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
    4ms
    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
    5ms
    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
    5ms
    A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=5, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=145 --> 5
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    Inlyta (axitinib) • INCB99280
    5ms
    A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=125 --> 6
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability)
    |
    Krazati (adagrasib) • INCB99280
    5ms
    A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=5, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    INCB99280
    6ms
    A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    INCB99280
    6ms
    Predicine to Present 9 Liquid Biopsy Studies at ASCO 2024 (Predicine Press Release)
    "Predicine, Inc...announced today that it will present data from 9 ctDNA studies at ASCO 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and drug resistance mechanism studies. The forthcoming data represents significant potential for the practical application of Predicine’s cutting-edge liquid biopsy technology in personalized cancer care, clinical trials, and Companion Diagnostic (CDx) development."
    P1 data
    |
    PredicineALERT™ • PredicineBEACON™ • PredicineCARE™
    |
    INCB99280
    7ms
    Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=182, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    INCB99280
    7ms
    A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=7, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open
    |
    INCB99280
    7ms
    NETOS: A personalized approach of neoadjuvant therapy, including INCB099280 monotherapy and bladder preservation, for muscle-invasive urothelial bladder carcinoma (MIBC) with ctDNA monitoring. (ASCO 2024)
    Single-agent pembrolizumab, given neoadjuvantly in patients with T2-4N0M0 MIBC, was effective in PURE-01 trial... Pts should have a predominant urothelial 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 • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
    |
    Signatera™
    |
    Keytruda (pembrolizumab) • cisplatin • INCB99280
    8ms
    Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Abramson Cancer Center at Penn Medicine
    New P1 trial • Pre-transplantation
    |
    INCB99280
    8ms
    A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=145, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Inlyta (axitinib) • INCB99280
    9ms
    A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=7, Not yet recruiting, Incyte Corporation
    New P1 trial
    |
    INCB99280
    1year
    A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation (clinicaltrials.gov)
    P1, N=125, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    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
    1year
    A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation (clinicaltrials.gov)
    P1, N=125, Not yet recruiting, Incyte Corporation | .
    New P1 trial • Combination therapy • Metastases
    |
    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
    over1year
    Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    MSI (Microsatellite instability) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Yervoy (ipilimumab) • INCB99280
    over1year
    A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Checkpoint inhibition • Enrollment open
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    INCB99280
    over1year
    A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=145, Not yet recruiting, Incyte Corporation
    New P1/2 trial
    |
    Inlyta (axitinib) • INCB99280
    over1year
    Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=203, Recruiting, Incyte Corporation | Trial completion date: Mar 2026 --> Oct 2025 | Trial primary completion date: Mar 2026 --> Jul 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    INCB99280
    over1year
    Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, Incyte Corporation
    New P1 trial • Combination therapy
    |
    MSI (Microsatellite instability) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Yervoy (ipilimumab) • INCB99280
    over1year
    A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=240, Not yet recruiting, Incyte Corporation
    New P2 trial • Metastases
    |
    INCB99280
    over1year
    A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive (clinicaltrials.gov)
    P2; N=314; Not yet recruiting; Sponsor:Incyte Corporation
    Checkpoint inhibition • New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    INCB99280