A Study of ZW191 in Participants With Solid Tumors

Phase 1RecruitingNCT06555744

Zymeworks BC Inc.145 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

145

Conditions

Advanced Solid Tumors

Interventions

ZW191DRUG

Administered intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Yale University

Outcomes

Primary Outcomes

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

Time frame: 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)

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

Secondary Outcomes

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

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

Central Contacts

Zymeworks Clinical Trial Resource

CONTACT

(206) 237-1030 medinfo@zymeworks.com

Data from ClinicalTrials.gov

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