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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of dose-limiting toxicities (DLTs; Part 1) — Up to 3 weeks Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW191
Incidence of adverse events (AEs; Parts 1 and 2) — Up to approximately 2 years Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
Incidence of clinical laboratory abnormalities (Parts 1 and 2) — Up to approximately 2 years Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Confirmed objective response rate (Part 2) — Up to approximately 2 years Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Trial sites (27)
Facility
City
Region
Status
Yale University
New Haven
Connecticut
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus
Ohio
Stephenson Cancer Center
Oklahoma City
Oklahoma
NEXT Oncology
San Antonio
Texas
NEXT Virginia
Fairfax
Virginia
Linear Clinical Research
Nedlands
Australia
Royal North Shore Hospital Northern Sydney Cancer Centre
St Leonards
Australia
National Cancer Center Hospital East
Kashiwa-shi
Japan
Saitama Medical University International Medical Center
Saitama
Japan
National Cancer Center Hospital
Tokyo
Japan
The Cancer Institute Hospital of JFCR
Tokyo
Japan
National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)
Singapore
Singapore
National Cancer Centre Singapore
Singapore
Singapore
Curie Oncology
Singapore
Singapore
National Cancer Center
Goyang-si
South Korea
Seoul National University Bundang Hospital
Seongnam-si
South Korea
Seoul National University Hospital
Seoul
South Korea
Severance Hospital, Yonsei University Health System
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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