Study on IMP9064 as a Standalone or Combined Treatment for Advanced Solid Tumors

Inclusion Criteria

• Must be 18 years or older.
• Must agree to participate voluntarily and sign a consent form.
• Have advanced solid tumors that have not responded to standard treatments or for which no standard treatment exists.
• Be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Provide a tumor tissue sample.
• Have a life expectancy of at least 12 weeks.
• Women must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for 6 months after.
• Men must agree to use effective birth control and not donate sperm during the study and for 6 months after.
• Be willing to comply with study visits and procedures.
• For optional analysis, be willing to provide eyebrow hairs and tumor biopsies before and after treatment.

Exclusion Criteria

• Allergic to any part of the study drug.
• Have received any cancer treatment within 28 days before starting the study drug.
• Have not recovered from previous treatment side effects.
• Have active or untreated brain cancer or meningitis.
• Have significant heart problems or abnormal heart rhythms.
• Have had major surgery or radiation therapy recently.
• Have active infections or a history of certain viral infections like HIV or hepatitis.
• Have active tuberculosis.
• Have tested positive for COVID-19 recently.
• Have other medical or psychiatric conditions that could interfere with the study.
• Have received any treatment targeting the ATR/CHK1 pathway.
• Have received a live vaccine recently.
• Are participating in another clinical trial.
• Have other cancers needing treatment within the last 2 years, except for certain skin cancers.
• Cannot swallow pills or have digestive issues affecting medication absorption.
• Have a history of alcoholism or drug abuse.