Study on OTP-01, a New Treatment for Advanced Solid Tumors

Inclusion Criteria

• Have a confirmed diagnosis of advanced solid tumors that cannot be cured, have come back, cannot be removed by surgery, or have spread to other parts of the body.
• For certain groups, patients must have a specific type of tumor and have tried standard treatments that are available and beneficial, unless these treatments are not suitable or are declined by the patient.
• Have measurable disease according to specific medical criteria, with some exceptions for breast or ovarian cancer.
• Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a life expectancy of at least 3 months.
• Be willing to provide a tumor sample before treatment, either from a previous biopsy or a new one.
• Have recovered from any side effects of previous cancer treatments to a mild level, except for hair loss or mild nerve damage.
• Have adequate blood, kidney, and liver function as determined by specific tests.

Exclusion Criteria

• Currently taking high doses of corticosteroids (more than 10 mg/day) within 4 weeks before joining the study, except for low-dose or non-systemic forms.
• Have had a severe allergic reaction to previous monoclonal antibody treatments or any ingredients in the study drug.
• Have had side effects from previous cancer immunotherapy that required stopping treatment.
• Have an active autoimmune disease that needed treatment in the past 2 years, except for replacement therapy.
• Have had an organ or stem cell transplant or need immunosuppressive treatment.
• Have high levels of protein in the urine.
• Have received chemotherapy, immunotherapy, or other investigational cancer treatments recently, within a specific timeframe before starting the study drug.
• Have had recent radiation therapy, with specific timeframes for different types of radiation.
• Other specific criteria as defined in the study protocol.