Study of INCA 0186 in Subjects With Advanced Solid Tumors

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.

Timeline

Start

2021-10-04

Primary completion

2024-09-19

Completion

2024-09-19

Publications

• Qi C, McCammant MS, Li Y, Zhu W, Yu Z, Carlsen P, Han H, Zhao L, Zhang F, Huang T, Gan P, Qian D, Hoang G, He C, Mei S, Harris JJ, Gallion A, Hansbury M, Mason J, Stump K, Kurzeja-Lipinski K, DiRamio A, Covington M, Koblish H, Diamond S, Wang H, Scherle P, Yao W, Wang X. Discovery of Dual A2A/A2B Adenosine Receptor Antagonist and Clinical Candidate INCB106385. J Med Chem. 2026 Jun 11;69(11):13899-13918. doi: 10.1021/acs.jmedchem.6c00964. Epub 2026 May 27.

Drugs

Indications