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Active (not recruiting) Phase 1 NCT06555744

A Study of ZW191 in Participants With Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumors

Sponsor: Zymeworks BC Inc.

trial.available_in: БГ
Overview
The purpose of this study is to find out if ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.
Description
Part 1 of the study will evaluate the safety and tolerability of ZW191. Part 2 of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.
Who can participate
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.
Interventions
ZW191
DRUG
Locations 27
Australia (2)
Linear Clinical Research
Nedlands
Royal North Shore Hospital Northern Sydney Cancer Centre
St Leonards
Japan (4)
National Cancer Center Hospital East
Kashiwa-shi
Saitama Medical University International Medical Center
Saitama
National Cancer Center Hospital
Tokyo
The Cancer Institute Hospital of JFCR
Tokyo
Singapore (3)
National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)
Singapore
National Cancer Centre Singapore
Singapore
Curie Oncology
Singapore
South Korea (7)
National Cancer Center
Goyang-si
Seoul National University Bundang Hospital
Seongnam-si
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Spain (6)
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Clínica Universidad de Navarra
Madrid
NEXT Oncology Madrid
Madrid
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia
Hospital Clinico Universitario de Valencia
Valencia
United States (5)
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus , Ohio
NEXT Virginia
Fairfax , Virginia
Yale University
New Haven , Connecticut
Stephenson Cancer Center
Oklahoma City , Oklahoma
NEXT Oncology
San Antonio , Texas
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.10.2024
Completion date
01.01.2027
Registry ID
NCT06555744
Source
clinicaltrials.gov
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