RNAZ•RNAZ•TransCode initiates Phase 2a study of TTX-MC138 in up to 45 ctDNA-positive colorectal cancer patients post curative-intent therapy, with FDA submission and IRB approval enabling site activation on QLHC’s PRE-I-SPY platform. The trial leverages NCCN-affiliated centers and aims to assess TTX-MC138’s biological and clinical activity in minimal residual disease.
TransCode Therapeutics has launched a Phase 2a clinical trial evaluating TTX-MC138 in up to 45 ctDNA-positive colorectal cancer patients who have completed standard curative-intent therapy and exhibit minimal residual disease without radiographic evidence. The study aims to assess TTX-MC138’s biological activity and clinical efficacy in reducing recurrence risk in this at-risk population.
The trial is conducted on the PRE-I-SPY platform sponsored by Quantum Leap Healthcare Collaborative and leverages FDA submission plus Institutional Review Board approval to activate leading cancer centers, including several NCCN members. Principal investigators from the University of Minnesota, Mayo Clinic, and MD Anderson will oversee patient enrollment across these experienced ctDNA-guided MRD sites.
TTX-MC138 is a first-in-class inhibitor targeting microRNA-10b to prevent metastatic progression in tumors overexpressing this biomarker. TransCode’s Phase 1a trial met its primary safety endpoint, established a recommended Phase 2 dose, and showed durable anti-tumor effects, providing a strong rationale for evaluating efficacy in the minimal residual disease setting.
