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 - M19-894

AbbVie B.V.0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月15日

试验速览

Trial ended prematurely

•- 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)

发起方