A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies

Exclusion Criteria

• •Female patients in pregnancy or lactation.
• •Patients with dysphagia; or a condition that seriously affects gastrointestinal absorption.
• •Allergic or intolerant to the active ingredients or excipients of the investigational product.
• •Anti-tumor therapy within 28 days of study day 1.
• •Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
• •Central nervous system (CNS) metastasis at screening.
• •Live vaccine therapy within 4 weeks before study drug administration.
• •Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
• •Use of prescription medications that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1.
• •Unresolved toxicity from prior anti-cancer therapy.
• •Active infection of HIV, HBV or HCV.
• •Patients who are judged by the investigator to have a history of other serious systemic diseases, or not suitable for participating in the trial for any other reason.