A Study of ZW191 in Participants With Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: ZW191

• Registration Number: NCT06555744
• Lead Sponsor: Zymeworks BC Inc.

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Study Start: 2024-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 145

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZW191	ZW191	-

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Clinical benefit rate (Parts 1 and 2)	Up to approximately 2 years	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
Confirmed objective response rate (Part 1)	Up to approximately 2 years	Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1
Best overall response (BOR; Part 2)	Up to approximately 2 years
Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)	Up to approximately 2 years	Maximum serum concentration and trough concentration of ZW191
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)	Up to approximately 2 years	Number of participants who develop ADAs
Disease control rate (DCR; Part 2)	Up to approximately 2 years	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
Duration of response (DOR; Part 2)	Up to approximately 2 years	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
Progression-free survival (PFS; Part 2)	Up to approximately 2 years	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

Trial Locations

Locations (6)

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

NEXT Virginia; 🇺🇸 Fairfax, Virginia, United States

Linear Clinical Research; 🇦🇺 Nedlands, Australia

Saitama Medical University International Medical Center; 🇯🇵 Saitama, Japan