First Patient Dosed in Phase I Trial of ZW191 for the Treatment of Advanced Cancers
Two-part study will evaluate the safety and tolerability of ZW191 in solid tumors across a variety of cancers including ovarian and endometrial.
Zymeworks announced it has dosed the first patient in its first-in-human Phase I clinical trial of ZW191. The study is evaluating the safety and tolerability of ZW191 for the treatment of advanced folate receptor-⍺ (FR⍺)-expressing solid tumors including ovarian, endometrial, and non-small cell lung (NSCLC) cancers.1
“Our team is excited to initiate this important clinical trial to assess the safety and tolerability of ZW191, our first antibody-drug conjugate utilizing ZD06519, our novel proprietary payload, in patients with difficult-to-treat cancers,” Jeff Smith, MD, FRCP, executive vice President and chief medical officer at Zymeworks said in a press release. “This global study represents a significant milestone in our mission to bring innovative and urgently needed therapies to patients in need. This announcement also follows the recent initiation of our Phase I trial of ZW171, marking an additional important step forward in advancing the many promising therapies in our wholly-owned pipeline.”
The two-part, multi-center, global Phase I study will enroll 145 adult patients with advanced FR⍺-expressing cancers at sites across North America, Europe, and the Asia-Pacific region. The first part of the study will evaluate the safety and tolerability of ZW191 with increasing doses in patients with advanced ovarian and endometrial cancer as well as NSCLC. Part two will continue to evaluate safety and explore potential anti-tumor activity.
Earlier in October, Zymeworks announced it had dosed the first patient of a different Phase I study evaluating ZW171, another of its investigational therapies. It is being evaluated for the treatment of advanced or metastatic ovarian cancer, NSCLC, and other MSLN-expressing cancers.2
In an earlier press release, 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 favorable 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.”
References
1. Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191 in Folate Receptor-⍺ Expressing Advanced Solid Tumors. News release. Zymeworks. November 5, 2024. Accessed November 7, 2024. https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-first-patient-dosed-phase-1-clinical-trial-0
2. Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW171 in Advanced Mesothelin-Expressing Cancers. News release. Zymeworks. October 21, 2024. Accessed November 7, 2024. https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-first-patient-dosed-phase-1-clinical-trial
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