Incyte terminates two Phase 2 trials of INCB099280

Incyte Corporation has terminated two Phase 2 clinical trials of its investigational drug candidate INCB099280, according to records updated on ClinicalTrials.gov on October 20, 2026.

The first trial, NCT05879822, enrolled participants with select advanced solid tumors who had not previously received immune checkpoint inhibitors. The study covered conditions including advanced solid tumors, hepatocellular carcinoma, cutaneous melanoma, PD-L1-positive NSCLC, non-small cell lung cancer, renal cell carcinoma, urothelial cancer, and MSI-H/dMMR tumors.¹ It enrolled 73 participants¹ and was terminated as a strategic business decision, with no safety concerns contributing to the decision.¹ The study started on October 30, 2023, and its primary and study completion dates were listed as September 30, 2026.¹

The second trial, NCT05888844, tested INCB099280 in patients with advanced cutaneous squamous cell carcinoma. It covered locally advanced and metastatic cutaneous squamous cell carcinoma² and enrolled 63 participants.² This study was also terminated as a strategic business decision, with no safety concerns contributing to the decision.² It started on October 9, 2023, with primary and study completion dates listed as September 28, 2026.²

In both trials, participants received INCB099280 at one of three doses administered twice daily, with a second part of each study using a dose selected from the first part. The primary outcome measure in both studies was objective response rate, along with monitoring of treatment-emergent adverse events. Neither registry record specifies the drug's route of administration.