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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

Trial Status: Active

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).

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).


Wayne State University / Karmanos Cancer Institute
Status: ACTIVE


Vanderbilt University / Ingram Cancer Center


M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization

  • Primary ID M19-894
  • Secondary IDs NCI-2020-03908, 2019-003167-22
  • ID NCT04196283