Tubulis has dosed the first subject in the multicentre Phase I/IIa 5-STAR 1-01 trial to clinically evaluate its second drug candidate, TUB-030, for advanced solid tumours.
The dose escalation and optimisation study will assess the pharmacokinetics, efficacy, safety, and tolerability of the antibody-drug conjugate (ADC) as a single agent.
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Approximately 130 subjects are set to be enrolled in this first-in-human study, which will take place in various locations across Canada and the US.
Phase I of the trial will focus on dose escalation to establish the safety profile and determine the maximum tolerated dose or the optimal dose for further study in subjects with advanced solid tumour indications.
Phase IIa will concentrate on dose optimisation and further evaluation of safety and preliminary efficacy in the chosen indications.
TUB-030 specifically targets the oncofoetal antigen 5T4, which is prevalent across a wide range of solid tumours.
It leverages the company’s Tubutecan linker-payload platform, which has been specially designed to improve biophysical properties and enable ‘sustained’ delivery of the payload.
The company previously reported extensive preclinical data that showcased the therapy’s stability and minimal loss of linker-payload conjugation.
The ADC has demonstrated potent and durable anti-tumour responses, even at low 5T4 expression levels, while maintaining an excellent safety and tolerability profile in several preclinical models.
Tubulis CEO and co-founder Dominik Schumacher said: “This milestone for TUB-030 demonstrates our ability to execute our strategy to advance innovative programmes into our proprietary pipeline and rapidly bring them into the clinic.
“As an organisation, Tubulis has made a large step forward with two differentiated ADC molecules in clinical evaluation in less than a year. Our goal is to continue being an innovation driver in the field by delivering on the transformative potential of our platforms for patients.”
