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

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).

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Abbvie

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