This study is being done to find out if ZW171 is safe and can treat participants with advanced (locally advanced \[inoperable\] and/or metastatic) mesothelin-expressing cancers.
Part 1 of the study will evaluate the safety and tolerability of ZW171. Part 2 of the study will evaluate the anti-tumor activity of ZW171 while continuing to evaluate the safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Administered per protocol requirements
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Incidence of dose-limiting toxicities (DLTs; Part 1)
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW171
Time frame: Up to 3 weeks
Incidence of adverse events (AEs; Parts 1 and 2)
Number of participants who experienced AEs or serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Incidence of cytokine release syndrome (CRS; Parts 1 and 2)
Number of participants who experienced CRS
Time frame: Up to approximately 2 years
Incidence of neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS; Parts 1 and 2)
Number of participants who experienced neurotoxicity, including ICANS
Time frame: Up to approximately 2 years
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
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
Time frame: Up to approximately 2 years
Confirmed objective response rate (Part 2)
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
Time frame: Up to approximately 2 years
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Norton Cancer Institute
Louisville, Kentucky, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center
New York, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Washington
Seattle, Washington, United States
Universitaetsklinikum Dresden
Dresden, Germany
Seoul National University Hospital
Seoul, South Korea
Yonsei University Health System - Severance Hospital
Seoul, South Korea
...and 5 more locations
Confirmed objective response rate (Part 1)
Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1
Time frame: Up to approximately 2 years
Duration of response (DOR; Part 2)
The time from the first objective response (CR or PR) to the first documented progressive disease (PD) per RECIST v1.1 or death within 30 days of last dose of study treatment from any cause. Only participants who achieve a confirmed response will be included in the analysis
Time frame: Up to approximately 2 years
Progression-free survival (PFS), including 1-year PFS (Part 2)
The time from the first dose of study treatment to the date of first documented PD per RECIST v1.1 or death from any cause
Time frame: Up to approximately 2 years
Disease control rate (DCR; Part 2)
Number of participants who achieved a best response of CR, PR, non-CR/non-PD (for participants who have only non-target lesions), or stable disease (SD) during treatment per RECIST v1.1
Time frame: Up to approximately 2 years
Overall survival (OS), including 1-year OS (Part 2)
The time from the first dose of ZW171 until the date of death from any cause
Time frame: Up to approximately 2 years
Serum concentration of ZW171 (Parts 1 and 2)
Maximum serum concentration and trough concentration of ZW171
Time frame: Up to approximately 7 months
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Number of participants who develop ADAs
Time frame: Up to approximately 7 months