A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 plus Tilsotolimod and Other Therapy Combinations in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Conditions
- head and neck cancerHead and neck squamous cell carcinoma10035227
- Registration Number
- NL-OMON49382
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
- At least 18 years old and weigh at least 35 kg
- Eastern Cooperative Oncology Group performance status of 0 or 1 and a life
expectancy of >= 3 months
- Have >= 1 lesion accessible for intratumoral injection and lesion(s) must be >=
2 cm in longest diameter.
- 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 (either in the definitive or
advanced, recurrent/metastatic setting), or be considered ineligible for
platinum-based therapy by the investigator.
- No uncontrolled metastases to the central nervous system (CNS). Subjects 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 subjects have not used prohibited levels of steroids for at least 4
weeks prior to first dose of the study.
- Must not have received prior treatment with OX40 or TLR agonists (excluding
topical agents)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method