Print

Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ZW251
  • Drug: ZW251
    Administered intravenously

Recruiting Locations

UCSF Comprehensive Cancer Center
San Francisco, California 94158

University of California Los Angeles - Cancer Care - Santa Monica (UCLA)
Santa Monica, California 90404

Norton Cancer Institute
Louisville, Kentucky 40202

START Midwest
Grand Rapids, Michigan 49546

Hackensack University Medical Center
Hackensack, New Jersey 07601

MD Anderson Cancer Center
Houston, Texas 77030

START San Antonio
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Zymeworks BC Inc.

Study Contact

Zymeworks Clinical Trial Resource
(206) 237-1030
medinfo@zymeworks.com

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.