Clinical Trial

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

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-12; most recent amendment 2025-10-16.
Trial Details
NCT Number NCT06597565
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Acrivon Therapeutics
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 43 participants
Start Date 2024-09-25
Primary Completion 2028-08-23 (estimated)
Study Completion 2028-08-23 (estimated)
Updated on ClinicalTrials.gov 2025-10-20