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
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Lead
AbbVie
With
Idera Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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).
Clareo Health | 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
