A Study of ZW171 in Participants with Advanced or Metastatic Mesothelin Expressing Cancers
Research type
Research Study
Full title
A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers
IRAS ID
1009919
Contact name
Phillip Farrell
Contact email
Sponsor organisation
Zymeworks BC Inc.
Clinicaltrials.gov Identifier
Research summary
This is a first-in-human, Phase 1 study to evaluate the use of ZW171 (study drug) in locally advanced (unresectable) and/or metastatic mesothelin (MSLN) expressing cancers, including but not limited to ovarian cancer, non-small cell lung cancer (NSCLC), and other MSLN expressing cancers that have progressed after all known prior therapies. Study ZWI-ZW171-101 has two parts, dose escalation (Part 1) and dose expansion (Part 2).
Dose escalation will include participants with ovarian cancer and NSCLC. Dose expansion may include, but not limited to, ovarian, NSCLC, and other MSLN expressing cancers.
The objective of the study is to assess the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumour activity of ZW171. This study will also assess the dose-limiting toxicity, maximum tolerated dose and/or maximum administered dose, and will determine the recommended dose(s) of ZW171 for the dose expansion part.
Up to approximately 160 adult participants are expected to take part in this study. The treatment will last until unacceptable toxicity or disease progression.
According to the International Agency for Research on Cancer, there were approximately 18 million new cases of cancer (excluding non-melanoma skin cancer) diagnosed in 2020, with 9.9 million cancer deaths worldwide. Lung and ovarian cancers account for 11.4% and 1.6%, respectively, of these new cancer diagnoses. Expected incidence and mortality rates, respectively, for lung cancer are 2,206,771 and 1,796,144 and for ovarian cancer are 313,959 and 207,252 (World Health Organisation 2020).
Lung cancer is the 3rd most common cancer in the UK, there are around 48,500 new lung cancer cases in the UK every year, accounting for 13% of all new cancer cases (2016-2018). Ovarian cancer accounts for 4% of all new cancer cases in females in the UK, there are around 7,500 new ovarian cancer cases in the UK every year (2016-2018) (Cancer Research UK).REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0245
Date of REC Opinion
5 Sep 2024
REC opinion
Further Information Favourable Opinion