Recruiting
Phase 1

ZW251

Sponsor:

Zymeworks BC Inc.

Code:

NCT07164313

Conditions

Hepatocellular Carcinoma

Squamous Cell Non-Small Cell Lung Cancer

Germ Cell Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ZW251

Study Details

Brief summary:

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

Hepatocellular Carcinoma

Squamous Cell Non-Small Cell Lung Cancer

Germ Cell Tumor

Study ID

NCT07164313

Start date

Oct 21, 2025

Status verified date

May, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ZW251

Interventions

ZW251

Administered intravenously

Primary outcome measure

  • Incidence of dose-limiting toxicities (DLTs; Part 1) [ Time Frame: Up to 3 weeks ]
  • Incidence of AEs (Parts 1 and 2) [ Time Frame: Up to approximately 2 years ]
  • Incidence of clinical laboratory abnormalities (Parts 1 and 2) [ Time Frame: Up to approximately 2 years ]
  • Objective response rate (Part 2) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Zymeworks Clinical Trial Resource

(206) 237-1030medinfo@zymeworks.com

Locations

UCSF Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Katie Kelley, MD

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

Recruiting

Santa Monica, California, United States, 90404

Principal Investigator:

Richard Finn, MD

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

John Hamm, MD FACP, FASCO

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Principal Investigator:

Sreenivasa Chandana, MD, PhD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

Martin Gutierrez, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065-6800

Principal Investigator:

Ghassan Abou-Alfa, MD, JD, MBA, PhD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ecaterina Dumbrava, MD

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Muralidhar Beeram, MD, MBBS

More Information

Sponsor

Zymeworks BC Inc.

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • GPC3-expressing cancer
  • hepatocellular carcinoma
  • antibody drug conjugate
  • ADC
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Squamous Cell Cancer
  • Germ Cell Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zymeworks BC Inc. on 2026-05-07.