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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors Cancer

In brief

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).

Key facts

Study ID

NCT04196283

Run by

AbbVie

People needed

30

Starts

2020-01-22

Expected to finish

2022-10-27

Last updated by the study team

2023-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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).

Where it is running

• The University of Chicago Medical Center /ID# 217196 — Chicago, Illinois, United States
• Norton Cancer Institute /ID# 216179 — Louisville, Kentucky, United States
• Barbara Ann Karmanos Cancer In /ID# 214050 — Detroit, Michigan, United States
• Nebraska Methodist Hospital /ID# 215786 — Omaha, Nebraska, United States
• Atlantic Health System /ID# 216159 — Morristown, New Jersey, United States
• Roswell Park Comprehensive Cancer Center /ID# 215882 — Buffalo, New York, United States
• Vanderbilt Ingram Cancer Center /ID# 214040 — Nashville, Tennessee, United States
• MD Anderson Cancer Center /ID# 214041 — Houston, Texas, United States
• Centre Antoine Lacassagne - Nice /ID# 215706 — Nice, Alpes-Maritimes, France
• AP-HM - Hopital de la Timone /ID# 215657 — Marseille, Bouches-du-Rhone, France
• Hopital Saint-Andre /ID# 215702 — Bordeaux, Gironde, France
• Institut Curie /ID# 215653 — Paris, Île-de-France Region, France
• Universitaetsklinikum Erlangen /ID# 214196 — Erlangen, Bavaria, Germany
• Universitaetsklinikum Leipzig /ID# 214200 — Leipzig, Saxony, Germany
• Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197 — Berlin, Germany
• The Chaim Sheba Medical Center /ID# 215229 — Ramat Gan, Tel Aviv, Israel
• Rambam Health Care Campus /ID# 215231 — Haifa, Israel
• Gastroenterology Institute, Division of Medicine /ID# 215862 — Jerusalem, Israel
• Antoni van Leeuwenhoek /ID# 215291 — Amsterdam, North Holland, Netherlands
• Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402 — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Universitario de Fuenlabrada /ID# 214263 — Fuenlabrada, Madrid, Spain
• Hospital Clinic de Barcelona /ID# 214264 — Barcelona, Spain
• Hospital Universitario 12 de Octubre /ID# 214198 — Madrid, Spain
• Hospital Universitario HM Sanchinarro /ID# 214110 — Madrid, Spain
• Hospital Universitario Virgen de la Victoria /ID# 214109 — Málaga, Spain

Full record on ClinicalTrials.gov

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