Study on CS2009 for Adults with Advanced Solid Tumors

Inclusion Criteria

• Must sign a consent form agreeing to participate.
• Willing to attend all study visits and follow the treatment plan.
• Must be 18 years or older.

Phase I:

• Have advanced solid tumors that cannot be removed by surgery, such as lung, kidney, liver, stomach, ovarian, or cervical cancer.
• Have tried standard treatments without success, or no standard treatments are available.

Phase II:

• Have advanced solid tumors that cannot be removed by surgery, including certain types of lung cancer.
• Have at least one tumor that can be measured by scans.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have good organ function.
• Agree to use effective birth control during the study and for 180 days after the last dose.
• Women must have a negative pregnancy test before starting the treatment.

Exclusion Criteria

• Have had another active cancer in the past 3 years, except for certain skin or localized cancers that have been treated.
• Have a brain tumor or cancer that has spread to the brain that is causing symptoms or needs treatment.
• Have uncontrolled fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
• Have taken steroids or other immune-suppressing drugs recently.
• Have a history of inflammatory bowel disease.
• Have lung diseases that required steroid treatment or are currently active.
• Have active infections needing treatment recently.
• Test positive for HIV or have AIDS.
• Have active hepatitis B or C, or tuberculosis.
• Have had major surgery or cancer treatments recently.
• Have received a live vaccine recently.
• Have had an organ or stem cell transplant.
• Have taken certain herbal or investigational drugs recently.
• Have allergies to the study drug or similar medications.
• Have unresolved side effects from previous treatments.
• Have a history of alcohol or drug abuse.
• Women who are pregnant or breastfeeding.
• Have other medical or psychiatric conditions that could increase risks during the study.