TransCode Therapeutics has announced the commencement of its Phase I clinical study of TTX-MC138, a therapeutic candidate designed to potentially treat patients with metastatic solid cancers.
The trial has activated two clinical sites, with patient enrolment expected to start within the current quarter.
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The company may expand up to five clinical trial sites, all expected to be operational this quarter.
This multicentre, open-label trial aims to collect vital data on the safety of TTX-MC138 in patients with diverse metastatic solid cancers and may also provide preliminary evidence of its clinical efficacy.
The study is structured into two parts: an initial dose-escalation phase to assess the safety and tolerability of increasing doses of TTX-MC138, followed by a dose-expansion phase.
During the dose-expansion phase, researchers will further investigate its safety, tolerability and anti-tumour activity in specific tumour types.
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By GlobalDataThese will be selected based on the initial findings from the dose-escalation phase.
Participants will continue treatment until they experience a dose-limiting toxicity (DLT), an adverse event (AE) leading to unacceptable toxicity, progression of disease or withdrawal of consent.
TransCode Therapeutics Operations senior vice-president Sue Duggan said: “We are thrilled to have garnered such high interest in TTX-MC138 from eminent oncologists working in some of the most respected clinical trial sites in the country.
“Advancing breakthrough RNA therapeutics science in the clinic is our primary goal as a biotechnology company at the cusp of innovative technology.”
In August last year, the company dosed the first subject in a first-in-human Phase 0 clinical trial of radiolabelled TTX-MC138 to treat advanced solid tumours.
The trial was designed to quantify the amount of TTX-MC138 delivered to metastatic lesions and assess the pharmacokinetics of the candidate.
