Study on GI-102 and Pasritamig for Treating Advanced Prostate Cancer

Inclusion Criteria

• Men aged 18 years or older.
• Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Diagnosed with advanced prostate cancer that can be measured or evaluated. Certain types of prostate cancer with small cell or neuroendocrine features are allowed, but not primary small cell carcinoma or similar types.
• Cancer that has spread and continues to grow despite at least one treatment targeting androgen receptors.
• PSA level of 2 ng/mL or higher at screening.
• No more than two previous treatments with taxane chemotherapy and no other chemotherapy except taxane.
• Previous surgical removal of the testicles or ongoing hormone therapy to keep testosterone levels low.
• Healthy organ and bone marrow function, and good heart health.
• Fully recovered from any side effects of previous cancer treatments.
• Willing to follow study procedures and use contraception as required by the study.

Exclusion Criteria

• Active or past cancer spread to the brain, spinal cord issues, or unstable spinal cord compression.
• Serious uncontrolled heart, lung, liver, autoimmune, infectious, or other systemic diseases.
• Active or recent serious infections, including tuberculosis, hepatitis B, or hepatitis C.
• Current or past lung inflammation or lung disease.
• Recent use of experimental drugs, certain immune-modulating drugs, radiation, major surgery, or other treatments not allowed by the study.
• Previous treatment with specific CD3-targeting therapies.
• Allergies to GI-102, pasritamig, or their ingredients, or any other condition that could affect participation or results.