A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers
NCT Number: NCT06523803
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Mesothelin-expressing Advanced Cancers
Interventions: DRUG: ZW171
Sponsor: Zymeworks BC Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12
Locations: Norton Cancer Institute, Louisville, Kentucky, 40202, United States

Summary:
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.

Primary Outcome Measures: 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, Up to 3 weeks|Incidence of adverse events (AEs; Parts 1 and 2), Number of participants who experienced AEs or serious adverse events (SAEs), Up to approximately 2 years|Incidence of cytokine release syndrome (CRS; Parts 1 and 2), Number of participants who experienced CRS, 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, 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, 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, Up to approximately 2 years
Secondary Outcome Measures: 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, 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, 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, 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, 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, Up to approximately 2 years|Serum concentration of ZW171 (Parts 1 and 2), Maximum serum concentration and trough concentration of ZW171, Up to approximately 7 months|Incidence of anti-drug antibodies (ADAs; Parts 1 and 2), Number of participants who develop ADAs, Up to approximately 7 months