A Study of ZW251 in Participants With Advanced Solid Tumors

Zymeworks

Status and phase

Enrolling

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: ZW251

Study type

Interventional

Funder types

Industry

Identifiers

NCT07164313

ZWI-ZW251-101

2025-523088-39 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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