Testing ZW191 for advanced solid tumors
A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants With Advanced Solid Tumors
This study is testing a new drug called ZW191 to see if it is safe and can help people with advanced solid tumors like ovarian, endometrial, and lung cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zymeworks BC Inc. Industry-sponsored |
| Locations | 17 sites (New Haven, Connecticut and 16 other locations) |
| Trial ID | NCT06555744 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of ZW191 in participants with advanced solid tumors, including ovarian, endometrial, and non-small cell lung cancers. The trial is divided into two parts: the first part focuses on assessing safety, while the second part explores the potential anti-tumor activity of the drug. Participants must have measurable disease and meet specific health criteria to be eligible for the study.
Who should consider this trial
Good fit: Ideal candidates are individuals with pathologically confirmed advanced solid tumors that are locally advanced, recurrent, or metastatic.
Not a fit: Patients with additional malignancies requiring active treatment or those who have previously received specific antibody drug conjugate treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers.
How similar studies have performed: Other studies have shown promise with similar approaches, but the specific application of ZW191 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease. * Measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA). * Other adequate organ function. Exclusion Criteria: * Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints. * Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period. * Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease. * Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.
Where this trial is running
New Haven, Connecticut and 16 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute — Columbus, Ohio, United States (Recruiting)
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
- Linear Clinical Research — Nedlands, Australia (Recruiting)
- Royal North Shore Hospital Northern Sydney Cancer Centre — St Leonards, Australia (Recruiting)
- National Cancer Center Hospital East — Kashiwa-shi, Japan (Recruiting)
- Saitama Medical University International Medical Center — Saitama, Japan (Recruiting)
- National Cancer Center Hospital — Tokyo, Japan (Recruiting)
- National Cancer Center — Goyang-si, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS) — Singapore, Singapore (Recruiting)
- National Cancer Centre Singapore — Singapore, Singapore (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.