Phase 1 S-adenosylmethionine (SAMe) methyl-donor supplement to modulate epigenetics/microbiome

This first-in-human, single-center, open-label Phase 1 dose-finding study tests daily oral S-adenosylmethionine (SAMe)—the body’s principal methyl-group donor used in cellular methylation reactions—as a potential chemopreventive approach after curative surgery for stage 1–2 colorectal cancer. Patients receive SAMe tablets for up to ~12 months (planned dose range ~1,600–2,400 mg/day in divided doses) with the primary goal of identifying a recommended Phase 2 dose based on tolerability and safety. Secondary objectives include post-op adenoma rates on surveillance colonoscopy plus paired pre/post stool sampling and distal colon biopsies to probe microbiome shifts and tissue biomarkers that might explain a preventive effect. The program is led at Cedars-Sinai by investigator-sponsor Jun Gong, rather than a pharma sponsor, and the commercial angle is repositioning a widely available supplement into a regulated oncology chemoprevention pathway with biomarker readouts. Today’s care for resected stage 1–2 colorectal cancer is surgery followed by surveillance (including interval colonoscopy) without adjuvant chemotherapy for many patients, so this explores a low-intensity adjunct intended to reduce new adenomas that can seed future cancers.