NCT04989387

Study of INCA 0186 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter Study of INCA00186 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

Conditions

• Advanced Solid Tumors
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Gastrointestinal (GI) Malignancies

Interventions

Type	Name	Description
DRUG	INCA00186	INCA00186 will be administered every 2 weeks or 4 weeks as per protocol
DRUG	Retifanlimab	Retifanlimab will be administered every 4 weeks as per protocol
DRUG	INCB106385	INCB106385 will be administered orally once or twice a day.

Timeline

• Start date: 2021-10-04
• Primary completion: 2024-09-19
• Completion: 2024-09-19
• First posted: 2021-08-04
• Last updated: 2025-09-02

Locations

32 sites across 6 countries: United States, Austria, Belgium, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study