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INCB099280

DRUG11 trials

Sponsors

Incyte Corp., Incyte Corporation, Abramson Cancer Center at Penn Medicine

Conditions

Advanced Solid TumorAdvanced Solid TumorsAdvanced Solid Tumors Harboring a KRASG12C MutationCervical CancerCutaneous Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaHealthy ParticipantsHepatoCellular Carcinoma

Phase 1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
CompletedNCT04242199
Incyte CorporationAdvanced Solid Tumor, Cervical Cancer, Cutaneous Squamous Cell Carcinoma +9
Start: 2020-09-04End: 2024-11-21Updated: 2025-07-14
A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors
TerminatedNCT05949632
Incyte CorporationAdvanced Solid Tumors
Start: 2024-04-16End: 2025-06-06Updated: 2026-06-04
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
TerminatedNCT06039384
Incyte CorporationAdvanced Solid Tumors
Start: 2023-12-28End: 2025-07-11Updated: 2026-09-08
A Phase I Study of INCB099280 in Combination With Ipilimumab in Participants With Selected Solid Tumors
CompletedCTIS2023-503243-34-00
Incyte Corp.Solid tumor
End: 2024-04-09Target: 23Updated: 2024-04-22
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
CompletedNCT06309394
Incyte CorporationHealthy Participants
Start: 2024-05-15End: 2024-06-04Updated: 2025-09-11
A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
CompletedCTIS2023-503223-26-00
Incyte Corp.Advanced Solid Tumors Harboring a KRASG12C Mutation
Start: 2024-05-07End: 2024-05-31Target: 75Updated: 2024-03-25
Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)
WithdrawnNCT06337162
Abramson Cancer Center at Penn MedicineHepatocellular Carcinoma
Start: 2024-05-01End: 2028-09-01Updated: 2024-08-09

Phase 2

A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
Active, not recruitingNCT05879822
Incyte CorporationAdvanced Solid Tumor
Start: 2023-10-30End: 2026-09-30Updated: 2026-09-02
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
Active, not recruitingNCT05888844
Incyte CorporationCutaneous Squamous Cell Carcinoma
Start: 2023-10-09End: 2026-09-28Updated: 2026-08-17
A PHASE 2 STUDY EVALUATING INCB099280 IN PARTICIPANTS WITH SELECT SOLID TUMORS WHO ARE IMMUNE CHECKPOINT INHIBITOR–NAÏVE
RecruitingCTIS2022-502716-37-00
Incyte Corp.Recurrent or advanced/metastatic solid tumors who are immunotherapy naive and may or may not have been treated with prior therapy for their disease.
Start: 2023-11-27Target: 70Updated: 2024-10-11
A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
RecruitingCTIS2022-502476-23-00
Incyte Corp.Treatment of immunotherapy-naive patients with previously untreated or recurrent locally advanced or metastatic cSCC not amenable to curative surgery and/or radiotherapy
Start: 2023-10-25Target: 97Updated: 2026-01-16

Related Papers

Circulating tumor DNA concentrations and blood tumor mutation burden as biomarkers of outcomes in a phase 1 study of select advanced solid tumors.
Journal of Clinical Oncology2025-05-28
NETOS: A personalized approach of neoadjuvant therapy, including INCB099280 monotherapy and bladder preservation, for muscle-invasive urothelial bladder carcinoma (MIBC) with ctDNA monitoring.
Journal of Clinical Oncology2024-06-01
A phase 1 study of the small-molecule PD-L1 inhibitor INCB099280 in select advanced solid tumors: Updated safety, efficacy, and pharmacokinetics (PK) results.
Journal of Clinical Oncology2024-06-01
159TiP Two phase I studies assessing the safety and efficacy of the small molecule oral PD-L1 inhibitor INCB099280 in combination with adagrasib (INCB 99280-204 [study 204]) or ipilimumab (INCB 99280-205 [study 205]) in adults with advanced solid tumors
Immuno-Oncology Technology2023-12-01