A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors

Inclusion criteria

• Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person.
• 18 to 75 years old, male or female.
• ECOG Performance Status of 0 or 1.
• The estimated survival time is ≥12 weeks.
• Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology.
• Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria.
• Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol.
• Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation.

Exclusion criteria

• Subjects plan to receive any other antitumor therapy during the study period.
• Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing.
• Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing.
• Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing.
• The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1.
• Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain.
• Active heart disease in the 6 months prior to initial dosing.
• Had other malignancies within 5 years prior to first dosing.
• Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy.
• Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion;
• Active hepatitis B and C;
• Serious infections that require intravenous antibiotics, antivirals or antifungals to control;
• History of immune deficiency or organ transplantation;
• Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.