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

  • End date
    Nov 25, 2022
  • participants needed
  • sponsor
Updated on 6 August 2021
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Rabin Medical Center /ID# 215230 (6.6 mi away) Contact
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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).

Condition Advanced Solid Tumors Cancer
Treatment Nab-paclitaxel, ABBV-181, ABBV-368, Tilsotolimod
Clinical Study IdentifierNCT04196283
Last Modified on6 August 2021


Yes No Not Sure

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
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

Exclusion Criteria

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)
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