A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC

The purpose of the study is to determine the activity and safety of ACR-368 (prexasertib) in combination with gemcitabine in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Participants will receive the study drugs ACR-368 and a low dose of gemcitabine once every 2 weeks in 4-week cycles and will continue on treatment unless the disease deteriorates.

Trial Details

NCT ID
NCT06597565
Phase
PHASE2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Gemcitabine
  • ACR-368
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related assessments/proce…
  • Must be able and willing to comply with the study visit schedule and protocol requirements.
  • Must have sufficient archived tumor tissue available for p16 immunohistochemistry (IHC) staining if the status is unknown. HPV status determined by…
  • Must have sufficient archived tumor tissue available for OncoSignature determination. The tumor tissue must be less than 3 months old from the enro…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HPV Positive Head and Neck Cancer Trials on Trialify →