Phase II Study of ACR-368 and Low Dose Gemcitabine for Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Must understand and sign a consent form before any study procedures.
• Willing to follow the study schedule and requirements.
• Must have enough stored tumor tissue for specific tests, or agree to a new biopsy if needed.
• Must agree to a biopsy after initial treatment and if the disease progresses.
• Must have recurrent or metastatic HNSCC, including specific areas like the oral cavity and throat.
• Must have had one prior treatment with PD-1/PD-L1 inhibitors, unless ineligible due to certain conditions.
• Must have at least one measurable tumor.
• Must be in good general health with an ECOG score of 0 or 1.
• Must meet specific lab test criteria, with support allowed if needed.
• Must agree to use effective birth control during and for one year after the study.

Exclusion Criteria

• No prior systemic therapy within four weeks before starting the study treatment.
• No palliative radiation therapy within two weeks before starting the study treatment, unless it does not involve target lesions.
• No severe side effects from previous treatments, except for certain conditions like hair loss or skin changes.
• No untreated or symptomatic brain metastases, unless treated and stable for at least two weeks.
• No significant heart problems, including low heart function or certain heart conditions.
• No uncontrolled high blood pressure or serious heart rhythm issues.
• No other cancers within the last three years, unless treated and not likely to return.
• Not pregnant, breastfeeding, or unable to give consent.
• Not in emergency situations without a representative to consent.