An Open-label Phase 2 Study of ACE-041 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Study Status

Closed to Enrollment

Study Description

This clinical trial is for people with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) who require treatment for their cancer.

The purpose of this study is to determine how well patients with SCCHN respond to treatment with the experimental drug ACE-041. The study will also:

  • evaluate the safety of the study drug
  • look at the amount of the study drug in the blood of people dosed with ACE-041
  • determine whether ACE-041 can stop SCCHN from growing, or prevent it from growing as fast as it would without treatment with the study drug
  • find out if the study drug has an effect on biomarkers (molecules that indicate how well people respond to a drug)

For cancer cells to grow they need to have nutrients supplied to them through blood vessels. ACE-041 is designed to work by blocking the growth of those blood vessels. By doing so, it may prevent cancer cells from growing.

Study participants will receive a dose of ACE-041, administered by subcutaneous injection, once every 3 weeks. The treatment period will last as long as a participant’s cancer is not getting worse. All study participants will receive ACE-041; there is no placebo.

Disease Status and/or Stage

Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck



Key Eligibility

  • Men and women age 18 and older
  • Recurrent or metastatic squamous cell cancer of the head and neck (SCCHN)
  • Previously treated with at least 1 platinum-containing regimen
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Elizabeta Popa, MD


Healthy Volunteers


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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