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

Inclusion Criteria:

* ≥ 18 years of age at the signing of ICF.
* Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who cannot be treated surgically and have failed standard of care (SoC). Or patients with refractory/relapsed lymphomas.
* MTAP deficiency is confirmed by IHC or NGS.
* At least one evaluable tumor lesion at screening for patients in escalation part, and at least one measurable tumor lesion for patients in expansion part.
* ECOG performance status of 0 to 1.
* Adequate hematopoietic function, cardiac function, liver function, renal function, and coagulation function per local laboratory.

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.