Testing ZW171 for advanced cancers that express mesothelin
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
This study is testing a new drug called ZW171 to see if it can safely help people with advanced cancers that have a specific protein called mesothelin when other treatments haven't worked.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zymeworks BC Inc. Industry-sponsored |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Trial ID | NCT06523803 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of ZW171, an antibody-drug conjugate, in patients with advanced or metastatic mesothelin-expressing cancers. The study is divided into two parts: the first part focuses on assessing the safety and tolerability of ZW171, while the second part examines its anti-tumor activity. Participants must have cancers that are either refractory to standard treatments or for which no standard treatment is available. The trial aims to provide insights into a new potential therapy for these challenging cancer types.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically confirmed advanced or metastatic mesothelin-expressing cancers who have exhausted standard treatment options.
Not a fit: Patients with additional malignancies that are progressing or those who have significant ongoing toxicity from prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced mesothelin-expressing cancers.
How similar studies have performed: While this approach is novel, similar studies involving antibody-drug conjugates have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable) and/or metastatic disease. Cancers that are refractory to all available standard of care (SOC) treatment, cancers for which no SOC treatment is available, or the participant cannot tolerate or refuses SOC therapy. * An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction ≥ 50% as determined by either echocardiogram or multigated acquisition scan. * Adequate organ function. Exclusion Criteria: * Known additional malignancy that is progressing or that has required active treatment. * Undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ transplantation within the last 5 years. * Ongoing, clinically significant toxicity (Grade ≥ 2) associated with prior cancer therapies, with the exception of alopecia. * Advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short-term (including participants with massive uncontrolled effusion \[pleural, pericardial\], pulmonary lymphangitis, active unresolved bowel obstruction, massive ascites \[requiring paracentesis \>2 times within 2 weeks prior to the first dose\], and over 50% liver involvement). * Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment). * Active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs.
Where this trial is running
Los Angeles, California and 12 other locations
- University of Southern California - Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- University of Colorado Health Sciences Center — Aurora, Colorado, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center — New York, New York, United States (Recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- Universitaetsklinikum Dresden — Dresden, Germany (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Yonsei University Health System - Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Seoul St. Marys Hospital — Seoul, Korea, Republic of (Recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
- Royal Marsden Hospital — Sutton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Zymeworks Clinical Trial Resource
- Email: medinfo@zymeworks.com
- Phone: (206) 237-1030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.