INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Summary

This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

Timeline

Start

2021-02-03

Primary completion

2024-01-22

Completion

2024-01-22

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