Study of PM54 with Immunotherapy for Adults with Advanced Cancers

Inclusion Criteria

• Must be 18 years or older and able to give informed consent.
• Have a confirmed diagnosis of advanced cancer that cannot be cured with surgery or other treatments.
• Have cancer that has progressed or returned after previous treatments.
• Have measurable tumors according to standard criteria.
• Have experienced disease progression after previous treatments.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Individuals with stable brain metastases may participate if they meet specific conditions, such as no recent seizures and no need for high-dose steroids.
• Have adequate blood counts and organ function based on specific lab tests.
• Have recovered from any previous surgeries or radiation treatments.
• Be willing to follow study procedures and provide biological samples.
• Women of childbearing potential must use effective contraception during the study and for 7 months after the last treatment. Men with partners of childbearing potential must use condoms during treatment and for 4 months after.

Exclusion Criteria

• Previous treatment with PM54 or similar drugs.
• Allergies to PM54, pembrolizumab, or their ingredients.
• Other cancers within the last 3 years, except for certain skin cancers or in-situ diseases.
• Cancer spread to the brain's lining (carcinomatous meningitis).
• Certain heart conditions, such as recent heart attacks or heart failure.
• Lung diseases requiring steroids or other treatments.
• Recent or unstable blood clots.
• Autoimmune diseases that may worsen with treatment.
• Uncontrolled infections or recent unexplained fever.
• Previous bone marrow or stem cell transplants.
• Other medical or social conditions that may interfere with the study.
• Recent use of certain medications or treatments without a proper washout period.
• Active HIV infection unless well-controlled with treatment.
• Active hepatitis C or B infections unless under control.
• Risk of complications from tumors near critical structures.
• Pregnant or breastfeeding women, and participants not using effective contraception.