TransCode Selects 4.8 mg/kg Dose After 64% Stabilization in Phase 1a Trial
RNAZ•TransCode Therapeutics completed its Phase 1a trial of TTX-MC138 in 16 metastatic cancer patients, reporting no dose-limiting toxicities across 0.8–4.8 mg/kg dosing and 64% of 14 evaluable patients achieving stable disease for six months. The company advanced 4.8 mg/kg into a Phase 2a colorectal cancer trial.
1. Phase 1a Trial Design and Safety Results
The Phase 1a trial enrolled 16 patients with metastatic cancers in four escalating dose cohorts (0.8, 1.6, 3.2 and 4.8 mg/kg) of TTX-MC138. Across all cohorts, no dose-limiting toxicities or significant treatment-related safety events were observed, meeting the study’s primary safety endpoint.
2. Efficacy and Disease Stabilization Outcomes
Among 14 evaluable patients, 9 (64%) achieved stable disease lasting at least six months based on RECIST criteria. The median treatment duration was 11.3 weeks, with individual patient exposure ranging from 2 to 20 cycles.
3. Dose Selection and Phase 2a Advancement
Based on tolerability and stabilization data, the company selected 4.8 mg/kg as the recommended Phase 2a dose. A new study has been initiated to assess efficacy in circulating tumor DNA–positive colorectal cancer following curative-intent therapy.
4. Notable Patient Responses and Ongoing Treatment
Three patients remain on study, receiving up to 21 treatment cycles, including one metastatic thyroid cancer patient with a 12-month stable disease response and a marked decline in thyroglobulin levels, underscoring potential therapeutic activity.
