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About
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).
Enrollment
Sex
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Volunteers
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.
Exclusion criteria
Uncontrolled metastases to the central nervous system (CNS).
Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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