A Study of ZW191 in Participants With Solid Tumors
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Advanced Solid Tumors
Спонсор: Zymeworks BC Inc.
Налично на:
БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Интервенции
ZW191
DRUG
Места на провеждане
27
Австралия (2)
Linear Clinical Research
Nedlands
Royal North Shore Hospital Northern Sydney Cancer Centre
St Leonards
Япония (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
Сингапур (3)
National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)
Singapore
National Cancer Centre Singapore
Singapore
Curie Oncology
Singapore
Южна Корея (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
Испания (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
САЩ (5)
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute