A Study of ZW191 in Participants With Solid Tumors
NCT Number: NCT06555744
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumors
Interventions: DRUG: ZW191
Sponsor: Zymeworks BC Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 145
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-01
Locations: NEXT Oncology, San Antonio, Texas, 78229, United States|NEXT Virginia, Fairfax, Virginia, 22031, United States

Summary:
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.

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 ZW191, Up to 3 weeks|Incidence of adverse events (AEs; Parts 1 and 2), Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs), 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|Clinical benefit rate (Parts 1 and 2), Number of participants who achieved a best response of CR, PR, non-CR/non-progressive disease (PD), or stable disease (SD) lasting at least 180 days per 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 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|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 SD during treatment per RECIST v1.1, Up to approximately 2 years|Progression-free survival (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|Best overall response (BOR; Part 2), Up to approximately 2 years|Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2), Maximum serum concentration and trough concentration of ZW191, Up to approximately 2 years|Incidence of anti-drug antibodies (ADAs; Parts 1 and 2), Number of participants who develop ADAs, Up to approximately 2 years