The trial is set to take place across investigator sites in Europe, the US and the Asia-Pacific region. Credit: Amnaj Khetsamtip / Shutterstock.

Canadian biotechnology company Zymeworks has dosed the first subject in a Phase I trial of ZW171 to treat advanced or metastatic ovarian cancer, non-small cell lung cancer (NSCLC) and other mesothelin-expressing cancers.

ZW171 is engineered to kill T cell-mediated tumour cells by concurrently targeting the extracellular domain of the mesothelin protein on tumour cells and the cluster of differentiation 3 on T cells.

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The first-in-human Phase I study is a two-part, multi-centre, open-label trial that is anticipated to enrol around 160 adult subjects with advanced mesothelin-expressing cancers.

The first part of the trial will focus on assessing ZW171’s tolerability and safety, involving dose escalation in advanced ovarian and NSCLC patients.

Secondary endpoints will evaluate pharmacokinetics alongside the confirmed objective response rate.

The study’s second part will assess ZW171’s anti-tumour activity across ovarian cancer and NSCLC cohorts, as well as a basket cohort for subjects with any mesothelin expression.

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This stage’s primary endpoints will examine tolerability and safety, while its secondary endpoints will evaluate the duration of response rates, progression-free survival and overall survival.

The trial is set to take place across investigator sites in Europe, the US and the Asia-Pacific region.

Zymeworks executive vice-president and chief medical officer Jeff Smith said: “We are very pleased to have initiated the clinical evaluation of ZW171 for the treatment of patients with ovarian cancer and NSCLC, where it has the potential to be a highly effective therapy with favourable tolerability based on our preclinical research results.

“Initiation of this trial marks a significant step forward in our effort to bring a potential new treatment to people living with difficult-to-treat cancers and highlights our goal to advance two therapeutic candidates, ZW171 and ZW191, into clinical studies in 2024.

“Our trial is designed to rapidly generate clinical data on our differentiated product profile relative to other mesothelin-expressing therapeutics in clinical development.”