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).
- 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.
- 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
Vanderbilt University / Ingram Cancer Center
M D Anderson Cancer Center
Trial Phase Phase I
Trial Type Treatment
- Primary ID M19-894
- Secondary IDs NCI-2020-03908, 2019-003167-22
- Clinicaltrials.gov ID NCT04196283