Phase III Study of Oral CTS3497 for Patients with Advanced MTAP-Deficient Solid Tumors and Lymphomas

What this Trial Is About

Researchers are studying CTS3497 in patients with metastatic or locally advanced solid tumors and lymphomas that lack the enzyme methylthioadenosine phosphorylase MTAP. This study has two phases Phase I focuses on evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and determining the maximum tolerated dose or recommended dose for Phase II. Phase II aims to assess the effectiveness and safety of CTS3497 in this patient group. Participants will receive CTS3497 orally in capsule form. Phase I includes a dose escalation with 7 pre-set dose groups followed by a dose expansion with 2 to 3 dose groups. Phase II involves administering the recommended Phase II dose to patients with MTAP homozygous deletion across different cancer types, including esophageal squamous cell carcinoma, pancreatic adenocarcinoma, biliary tract cancer, non-small cell lung carcinoma, malignant pleural mesothelioma, urothelial cancer, high-grade gliomas, other solid tumors, and lymphomas. During the study, patients will be closely monitored for dose-limiting toxicities and treatment-emergent side effects for up to 52 weeks. Researchers will assess tumor response, disease control, duration of response, progression-free and overall survival, along with pharmacokinetic and pharmacodynamic characteristics of CTS3497 at specific times during treatment cycles. The total observation period may last up to approximately 3 years, ensuring thorough safety and efficacy evaluations.

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