A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Summary

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Timeline

Start

2020-01-22

Primary completion

2022-10-27

Completion

2022-10-27

Publications

• Daste A, Le X, Makkouk A, Patel M, Le Tourneau C, Perets R, Popovtzer A, Ochsenreither S, Haderlein M, Oliva M, Sukari A, Hong J, Blaney M, Ramathal C, McDevitt M, Rosenberg AJ. Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma. J Immunother Cancer. 2026 Apr 9;14(4):e014086. doi: 10.1136/jitc-2025-014086.

Drugs

Indications