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DRUG:

INCB99280

i
Other names: INCB99280, INCB099280
Associations
Company:
Incyte
Drug class:
PD-L1 inhibitor
Related drugs:
Associations
13d
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
3ms
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P1, N=0, Withdrawn, Abramson Cancer Center at Penn Medicine | N=15 --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 Withdrawn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
3ms
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
4ms
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
Trial completion
|
INCB99280
6ms
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
6ms
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
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
1year
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
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
1year
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
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
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
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
New P2 trial • Metastases
|
INCB99280
over1year
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