Zymeworks has dosed the first patient in its Phase I clinical trial of ZW191, an investigational therapy, aimed at treating advanced solid tumours that express folate receptor-α (FRα).
This therapy is intended for the treatment of endometrial, ovarian and non-small cell lung (NSCLC) cancers.
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ZW191 has demonstrated greater anti-tumour activity compared to standard FRα-expressing tumour models in data presented at the American Association for Cancer Research (AACR) Annual Meeting last year.
The first-in-human, two-part, multi-centre, global Phase I study is planning to enrol 145 adult patients.
Patients will be recruited from investigator sites across Europe, North America and the Asia-Pacific region.
The study’s first part will focus on the tolerability and safety of ZW191, including dose escalation in subjects with advanced endometrial, ovarian and NSCLC cancers.
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By GlobalDataSecondary endpoints will measure pharmacokinetics and the confirmed objective response rate.
The second part will assess the safety of ZW191 and explore its potential anti-tumour activity.
Zymeworks recently commenced a first-in-human Phase I trial of ZW171, targeting advanced or metastatic ovarian cancer, NSCLC, and other mesothelin (MSLN)-expressing cancers.
ZW191 is an antibody-drug conjugate specifically engineered to target FRα, a protein found on the surface of various tumour cells, including ovarian, endometrial, and lung cancers.
Its design allows for internalisation into FRα-expressing cells and the release of a bystander active topoisomerase-1 inhibitor (ZD06519), a new payload developed by Zymeworks to destroy tumour cells.
Zymeworks executive vice-president and chief medical officer Jeff Smith said: “Our team is excited to initiate this important clinical trial to assess the safety and tolerability of ZW191, our first antibody-drug conjugate utilising ZD06519, our novel proprietary payload, in patients with difficult-to-treat cancers.
“This global study represents a significant milestone in our mission to bring innovative and urgently needed therapies to patients in need.”
FRα is prevalent in around 70% of lung adenocarcinomas and 75% of high-grade serous ovarian carcinomas.
