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Study identifier: NCT07744126 Synced from ClinicalTrials.gov · August 04, 2026
● Not Yet Recruiting

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

Condition: Head and Neck Squamous Cell Carcinoma  ·  Sponsor: AbbVie

PhasePhase 2
Planned participants150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

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Locations (20)

University of Arkansas for Medical Sciences /ID# 283444Little Rock, Arkansas, United States
Winship Cancer Institute of Emory University /ID# 282003Atlanta, Georgia, United States
University of Chicago Medical Center /ID# 281748Chicago, Illinois, United States
OU Health - Stephenson Cancer Center /ID# 282905Oklahoma City, Oklahoma, United States
UT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center /ID# 283638Dallas, Texas, United States
University of Virginia /ID# 281773Charlottesville, Virginia, United States
Anhui Cancer Hospital /ID# 282354Hefei, Anhui, China
People's Hospital of Henan Province /ID# 282036Zhengzhou, Henan, China
Hunan Province Cancer Hospital /ID# 282346Changsha, Hunan, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 282115Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center /ID# 282374Shanghai, Shanghai Municipality, China
Aichi Cancer Center /ID# 282273Nagoya, Aichi-ken, Japan

+ 8 more locations — full list on the registry record.

Sponsor or site team? See the site landscape for this trial — listed sites, countries, and recruiting-density context.

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