for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



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).

Official Title

A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma


Advanced Solid Tumors Cancer Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma Locally Advanced Head and Neck Squamous Cell Carcinoma Metastatic Head and Neck Squamous Cell Carcinoma Cancer Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Paclitaxel Albumin-Bound Paclitaxel ABBV-368 Tilsotolimod Nab-paclitaxel ABBV-181


You can join if…

Open to people ages 18 years and up

  • Participants should weigh at least 35 kg.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of >= 3 months.
  • Participant have >= 1 lesion accessible for intratumoral injection.
  • Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during or after <= 3 prior treatment regimens administered in the recurrent or metastatic setting.
  • Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor.
  • Must have received platinum-based therapy, or be considered ineligible for platinum-based therapy by the investigator.

You CAN'T join if...

  • Uncontrolled metastases to the central nervous system (CNS).
  • Participants with brain metastases are eligible provided that evidence of clinical and radiographic stable disease for at least 4 weeks after definitive therapy is given and participants have not used prohibited levels of steroids for at least 4 weeks prior to first dose of the study.
  • Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).


  • UCSD Moores Cancer Center - LaJolla /ID# 216181 not yet accepting patients
    La Jolla California 92093 United States
  • Nebraska Methodist Hospital /ID# 215786 accepting new patients
    Omaha Nebraska 68114 United States


accepting new patients
Start Date
Completion Date
Phase 1
Study Type
Last Updated