Study on the Safety and Effectiveness of Oral NRC-2694-A with Paclitaxel for Patients with Recurrent or Metastatic Head and Neck Cancer After Immune Therapy

Inclusion Criteria

• Must be able to understand and sign a consent form.
• Must be 18 years or older.
• Must have a confirmed diagnosis of head and neck cancer that cannot be removed by surgery and has returned or spread.
• Must have cancer that has progressed after treatment with immune therapies like pembrolizumab or nivolumab.
• Must have a measurable tumor.
• Must be in relatively good health with an ECOG performance status of 0 to 2.
• Women of childbearing potential must have a negative pregnancy test before joining the study and use effective birth control during the study and for 30 days after the last dose.
• Must have adequate blood cell counts, kidney, and liver function as determined by specific tests.
• Must have stopped immune therapy at least 4 weeks before starting the study and recovered from any side effects.

Exclusion Criteria

• Have uncontrolled heart, liver, lung, or autoimmune diseases.
• Have untreated or uncontrolled brain metastases.
• Have a history of heart rhythm problems or risk factors for heart issues.
• Have previously received certain cancer treatments like cetuximab for recurrent or metastatic disease.
• Are currently in another clinical trial or receiving experimental treatments.
• Have certain types of head and neck cancers like nasopharyngeal or salivary gland cancers.
• Are pregnant or breastfeeding, or planning to become pregnant or father a child during the study.
• Have active infections or have had major surgery recently.
• Have a history of drug or alcohol abuse.
• Have received paclitaxel or docetaxel for metastatic or recurrent head and neck cancer, except as part of a previous treatment plan for locally advanced cancer.