Adcentrx plans to recruit up to 80 patients in the potentially international Phase Ib part. Credit: Huen Structure Bio via Shutterstock.

Adcentrx Therapeutics is actively evaluating options to open international sites in its ongoing Phase Ia/Ib trial investigating ADRX-0706 in advanced solid tumours, CEO Dr Hui Li told Clinical Trials Arena.

The US-based biotech is considering opening sites in Asia or Europe in the Phase Ib dose expansion part of the trial to expedite recruitment. The Ia dose escalation portion is being conducted in the US.

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ADRX-0706 is an antibody-drug conjugate (ADC), which targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis.

In September, Adcentrx dosed the first patient in the trial (NCT06036121). In the Phase Ia part, the biotech plans to enrol 45 patients with advanced solid tumours.

The trial will investigate five different doses of ADRX-0706 to evaluate the tolerability limit, as well as pharmacokinetics and safety profiles. Adcentrx plans to read out preliminary dose escalation data in mid-2024.

The Phase Ia data will indicate which solid tumours should progress to Phase Ib.

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“We are potentially looking for two to three different Nectin-4 expressing tumour indication,” said Li.

Depending on the selection, Adcentrx may recruit up to 80 participants in the Phase Ib part.

Next steps for ADRX-0706

Once Adcentrx completes the Phase Ia/Ib trial, the biotech will be able to start designing its pivotal trial with ADRX-0706. If everything goes according to plan, the next trial may be initiated towards the end of 2025.

Li explained that because ADC is part of precision medicine, the completion of a Phase Ib trial can lead to a pivotal study fairly quickly. Typically, Phase II trials explore different indications that are most suitable for the investigated molecule, but in the ADC space it is more streamlined, he added.

Data from the ongoing Phase Ia/Ib trial will determine the indication selection and cohort size of the registrational study. Similar to the Phase Ib portion, Adcentrx may open international sites to speed up recruitment. The decision will also be driven by selected indication prevalence.

Competitive ADC landscape

ADCs are a new class of biopharmaceutical drugs composed of an antibody that is linked via a chemical linker to a cytotoxic payload. According to GlobalData, the parent company of Clinical Trials Arena, more than 160 companies are engaged in the development and application of ADC cancer therapies.

A recent GlobalData report indicated that ADC space saw a 400% growth in total licensing agreement deal value from 2017 to 2022, reaching a $16.6bn peak in 2022.