A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Starting soon · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide with an annual incidence of approximately 700,000 cases. This study aims to evaluate the change in disease activity and optimal dose, and optimal dose of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment in participants with recurrent or metastatic head and neck squamous cell carcinoma. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of recurrent or metastatic HNSCC. Participants are placed into 3 treatment groups called treatment arms. Each group receives a different treatment. Adult participants diagnosed with recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease and whose tumors express c-Met protein will be enrolled. Approximately 180 participants will be enrolled in the study at sites worldwide. Participants will receive intravenous doses of telisotuzumab adizutecan with intravenous pembrolizumab, or standard of care (SOC) chemotherapy with pembrolizumab. Participants will receive treatment as part of a 38 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits every 3 weeks during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key facts

Study ID: NCT07744126
Run by: AbbVie
People needed: 150
Starts: 2026-09-30
Expected to finish: 2029-10-01
Last updated by the study team: 2026-08-04

Who can join

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

You may qualify if…

Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies.
Eastern cooperative oncology group (ECOG) performance status must be <= 1.
Must have c-Met protein expression by central c-Met immunohistochemistry (IHC) staining at any intensity in >= 25% tumor cells.
Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
Must have had no prior systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

You may not qualify if…

Have history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis on screening chest computed tomography (CT) scan.
Have any major, life-threatening conditions.
Life expectancy should be at least 3 months.

Where it is running

University of Arkansas for Medical Sciences /ID# 283444 — Little Rock, Arkansas, United States
Winship Cancer Institute of Emory University /ID# 282003 — Atlanta, Georgia, United States
University of Chicago Medical Center /ID# 281748 — Chicago, Illinois, United States
OU Health - Stephenson Cancer Center /ID# 282905 — Oklahoma City, Oklahoma, United States
UT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center /ID# 283638 — Dallas, Texas, United States
University of Virginia /ID# 281773 — Charlottesville, Virginia, United States
Anhui Cancer Hospital /ID# 282354 — Hefei, Anhui, China
People's Hospital of Henan Province /ID# 282036 — Zhengzhou, Henan, China
Hunan Province Cancer Hospital /ID# 282346 — Changsha, Hunan, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 282115 — Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center /ID# 282374 — Shanghai, Shanghai Municipality, China
Aichi Cancer Center /ID# 282273 — Nagoya, Aichi-ken, Japan
Yokohama City University Hospital /ID# 282274 — Yokohama, Kanagawa, Japan
Osaka International Cancer Institute /ID# 282269 — Osaka, Osaka, Japan
Hospital da Luz /ID# 282666 — Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 281306 — Loures, Lisbon District, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 281288 — Almada, Setúbal District, Portugal
Unidade Local de Saude de Santa Maria /ID# 281281 — Lisbon, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 281282 — Porto, Portugal
Hospital Universitario de Salamanca /ID# 282672 — Salamanca, Spain

Full record on ClinicalTrials.gov

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