A Study of ZW251 in Participants With Advanced Solid Tumors

NCT ID: NCT07164313

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2028-05-31

Brief Summary

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The purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC).

Detailed Description

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Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.

Conditions

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Hepatocellular Carcinoma

Keywords

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GPC3-expressing cancer hepatocellular carcinoma antibody drug conjugate ADC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZW251

Group Type EXPERIMENTAL

ZW251

Intervention Type DRUG

Administered intravenously

Interventions

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ZW251

Administered intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis
* Measurable disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Liver function status of Child-Pugh Class A
* Adequate organ function

Exclusion Criteria

* Known additional malignancy that is progressing or that has required active treatment within the last year
* History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy
* Portal vein thrombosis within 3 months prior to Cycle 1 Day 1 that require coagulation therapy or is not stable
* Known gastrointestinal bleeding within 3 months
* Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zymeworks BC Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maggie Weinstein, MD, PhD, MPH

Role: STUDY_DIRECTOR

Zymeworks BC Inc.

Locations

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Norton Cancer Institute

Louisville, Kentucky, United States

Site Status RECRUITING

START Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

START San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Zymeworks Clinical Trial Resource

Role: CONTACT

Phone: (206) 237-1030

Email: [email protected]

Other Identifiers

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2025-523088-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZWI-ZW251-101

Identifier Type: -

Identifier Source: org_study_id