A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors

Exclusion Criteria

• •1. History of other malignant tumors within the past 5 years；
• •2. Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.
• •3. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.
• •4. The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.
• •5. Uncontrolled pleural, pericardial, or peritoneal effusions.
• •6. Severe cardiac diseases occurring within 6 months prior to the first dose.
• •7. Arterial/venous thrombosis within 6 months before the first dose.
• •8. Clinically significant bleeding symptoms or predisposition within 3 months prior to the first dose.
• •9. Active infection or fever of unknown origin \> 38.5 ° C was present within 4 weeks before the first administration of the study
• •10. History of immunodeficiency.
• •11. Active hepatitis B or C.
• •12. Diseases affecting drug absorption/transport (e.g., malabsorption syndromes).
• •13. A history of severe allergic reactions to HRS-6719 and its main components was known or suspected, or there was a history of delayed allergic reactions, eczema or asthma that could not be controlled by topical corticosteroids.
• •14. Use of strong CYP3A4/P-gp inhibitors/inducers within 5 half-lives before the first dose.
• •15. Adverse events (AEs) from prior anti-tumor therapy not resolved to CTCAE v5.0 ≤ Grade 1.
• •16. Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or clinically significant pulmonary fibrosis, persistent pneumonia, pneumonia caused by drug or radiotherapy, congenital pneumonia, or chest CT scan found any evidence of active pneumonia.
• •17. Through medical history or CT examination, it was found that there was active pulmonary tuberculosis infection within 1 year before enrollment, or more than 1 year ago, there was a history of active pulmonary tuberculosis infection but no formal treatment.
• •18. Live attenuated vaccines administered within 4 weeks before the first dose or planned during the study.
• •19. Other factors potentially compromising study safety or data integrity.