A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma

Exclusion Criteria

• •1. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).
• •2. Previously received MAT2A or PRMT5 inhibitors.
• •3. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.
• •4. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.
• •5. History of other primary malignancies within 5 years prior to the first dose.
• •6. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.
• •7. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.
• •8. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.
• •9. Active infection requiring systemic anti-infective treatment at screening.
• •10. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.
• •11. Uncontrolled or significant cardiovascular disease.
• •12. Poorly controlled diabetes.
• •13. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.
• •14. History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.
• •15. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.
• •16. Serious thromboembolic events within 6 months prior to the first dose.
• •17. Active tuberculosis at screening.
• •18. Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.
• •19. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.
• •20. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
• •21. History of alcohol abuse or drug abuse.
• •22. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.
• •23. Pregnant or breastfeeding women.
• •24. Other conditions deemed unsuitable for participation in this trial by the investigator.