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A Study of ZW251 in Participants With Advanced Solid Tumors

RecruitingPhase 1

A First-In-Human, Phase 1, Open-Label, Multicenter Study of ZW251, a Novel Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors, Including Hepatocellular Carcinoma

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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
* Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic disease
* Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease
* 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 (for HCC only)
* 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
* Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment
* Known gastrointestinal bleeding within 3 months
* Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease

About the study

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), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).

What is being tested

Sponsor: Zymeworks BC Inc. · Participants: 100 · Started: Oct 21, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07164313

Locations in the U.S.

CaliforniaUCSF Comprehensive Cancer Center, San Francisco
University of California Los Angeles - Cancer Care - Santa Monica (UCLA), Santa Monica
KentuckyNorton Cancer Institute, Louisville
MichiganSTART Midwest, Grand Rapids
New JerseyHackensack University Medical Center, Hackensack
New YorkMemorial Sloan Kettering Cancer Center, New York
TexasMD Anderson Cancer Center, Houston
START San Antonio, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.