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RecruitingPhase 1

A Study of ZW251 in Participants With Advanced Solid Tumors

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ZW251 is safe and can treat advanced cancers. ZW251 is an antibody linked to a drug that targets a protein called GPC3. It is for people with certain liver, lung, or germ cell cancers.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have one of the confirmed cancer types listed below that cannot be removed by surgery or has spread to other parts of the body.
  • Liver cancer called hepatocellular carcinoma (HCC); if locally advanced, a liver transplant must not be an option.
  • A type of lung cancer called squamous cell non-small cell lung cancer.
  • A germ cell tumor made mostly of yolk sac tumor cells, choriocarcinoma cells, or both.
  • Have cancer that can be measured using the study’s rules.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • For people with HCC, have well-preserved liver function, called Child-Pugh Class A.
  • Have organs that work well enough for the study.

Who can't join

  • Have another cancer that is getting worse or needed active treatment within the past year.
  • Have had brain problems caused by liver disease in the past 6 months, or need medicine to control them.
  • For people with HCC, cancer in the main portal vein—the main vein bringing blood to the liver—requires study sponsor approval to join.
  • Have had bleeding in the stomach or intestines within the past 3 months.
  • Have uncontrolled kidney disease, swelling of the pancreas, or liver disease not caused by cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (8)

CA

  • UCSF Comprehensive Cancer Center · San Francisco, CA 94158Katie Kelley, MD · Principal investigatorMore trials in San Francisco
  • University of California Los Angeles - Cancer Care - Santa Monica (UCLA) · Santa Monica, CA 90404Richard Finn, MD · Principal investigatorMore trials in Santa Monica

KY

MI

NJ

  • Hackensack University Medical Center · Hackensack, NJ 07601Martin Gutierrez, MD · Principal investigatorMore trials in Hackensack

NY

  • Memorial Sloan Kettering Cancer Center · New York, NY 10065-6800Ghassan Abou-Alfa, MD, JD, MBA, PhD · Principal investigatorMore trials in New York

TX