A partnership comprising TransCode Therapeutics and Quantum Leap Healthcare Collaborative has submitted an investigational new drug (IND) application amendment seeking approval from the US Food and Drug Administration (FDA) for a planned Phase IIa trial of its lead colorectal cancer candidate, TTX-MC138.

The study will run within Quantum Leap’s PRE-I-SPY programme, marking the platform’s initial expansion into colorectal cancer.

Its dose-expansion portion will enrol up to 45 colorectal cancer patients who have finished standard curative-intent treatment and have positive circulating tumour DNA (ctDNA) markers.

Recent research has indicated that ctDNA may serve as a prognostic marker for cancer recurrence and could signal minimal residual disease (MRD) that may benefit from early intervention.

Scheduled to begin in the first half of 2026, the Phase IIa clinical trial will be led by principal investigator Dr Paula Pohlmann from MD Anderson Cancer Center.

It aims to assess TTX-MC138’s biological and clinical activity in patients with MRD following primary therapy.

Clinical trial activities will take place across several PRE-I-SPY Platform Network sites, with many belonging to the National Cancer Center Network. The programme is also collaborating with the Colorectal Cancer Alliance.

TransCode operations senior VP Sue Duggan said: “This IND submission marks a pivotal step in TransCode's clinical development programme, positioning TTX-MC138 where its mechanism of action has the potential to deliver meaningful benefit to patients.

“We are pleased to partner with Quantum Leap's PRE-I-SPY programme to evaluate TTX-MC138 and to support the expansion of this platform into new indications such as colorectal cancer.”

In March 2025, TransCode received unanimous approval from the Safety Review Committee (SRC) to open the fourth cohort in its Phase I trial of TTX-MC138 for treating several metastatic cancers.