Phase 1 Study of Oral Aza-TdC for Adults With Advanced Solid Tumors Resistant to Standard Treatments

What this Trial Is About

Researchers are evaluating a new drug called Aza-TdC for people aged 18 and older with advanced solid tumors whose cancer has worsened after standard treatments or has no effective therapy. This early-phase trial aims to test the safety, tolerability, and best dose of oral Aza-TdC, which is designed to reactivate tumor suppressor genes by inhibiting DNA methylation, potentially slowing tumor growth. Participants will take Aza-TdC by mouth in 21-day cycles. For the first two weeks of each cycle, they take the drug once daily for five days followed by two days off, then no drug in the third week. The study uses an accelerated dose escalation approach and may allow dose increases within participants. Testing includes blood samples for drug levels and gene activity, tumor scans every six weeks, and biopsies in some cases to study drug effects on tumors. During the study, participants undergo screening with medical history, blood and urine tests, heart electrical activity tests, and tumor imaging. Blood and pregnancy tests occur regularly, along with tumor biopsies for some participants. Researchers will measure safety, drug behavior in the body, gene reactivation, and tumor response. Treatment cycles continue as long as the drug is tolerated and cancer remains stable or improves. The study is sponsored by the National Cancer Institute and lasts until September 2026.

5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors