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

This study is testing the combination of a new drug called ACR-368 with low-dose gemcitabine (a chemotherapy drug) in patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) — cancers of the mouth, throat, voice box, or upper throat. **You may be eligible if...** - You have confirmed head and neck squamous cell cancer that has come back or spread - You have already been treated with at least one immunotherapy drug (PD-1/PD-L1 inhibitor), or are ineligible for immunotherapy due to autoimmune disease - You have at least one measurable tumor on imaging - You have good functional status (ECOG 0-1) - You are willing to undergo a biopsy **You may NOT be eligible if...** - You have had cancer treatment (chemotherapy, radiation, etc.) within the past 4 weeks - You have significant cardiac problems including heart failure, dangerous arrhythmias, or prolonged QT interval - You have another active cancer diagnosed in the past 3 years - You are pregnant or breastfeeding - You have symptomatic brain metastases Talk to your doctor to see if this trial is right for you.