Study on GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo for Patients with Advanced Melanoma and Head and Neck Cancer

Inclusion Criteria

• Have melanoma that cannot be removed by surgery or has spread, including unknown primary or mucosal melanomas, confirmed by a previous biopsy.
• Have head and neck squamous cell carcinoma that has come back or spread after treatment with platinum-based chemotherapy.
• Have not received anti-PD1 or anti-PD-L1 treatment in the last 6 months, or if they have, the cancer must have progressed.
• Be 18 years or older.
• Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use birth control.
• No active bleeding.
• Expected to live for more than 12 weeks.
• Must sign a consent form to participate in the study.

Exclusion Criteria

• Have previously received a galectin antagonist.
• Have active autoimmune diseases, except for autoimmune thyroiditis or vitiligo.
• Have a history of autoimmune colitis.
• Have untreated brain metastases, unless they have been treated and are stable.
• Require other cancer treatments, including experimental ones.
• Have received cancer treatment within 3 weeks or 5 half-lives before the first study drug dose.
• Have severe liver impairment (Child-Pugh C).
• Have an active infection needing antibiotics.
• Are pregnant or breastfeeding.
• Need steroids at doses higher than normal replacement levels, except for inhaled steroids.
• Have certain lab test results outside specified limits, such as low white blood cell or platelet counts, or high liver enzymes.
• Have active or known history of HIV, Hepatitis B, or Hepatitis C.
• Cannot give informed consent or follow the study procedures.
• Have any medical condition that could affect the safety or conduct of the study.
• Have unresolved immune-related lung inflammation, diarrhea, or liver enzyme issues requiring high doses of steroids.