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New Antibody-Drug conjugate ZW251 enters first human trials for Hard-to-Treat cancers

NCT ID NCT07164313

Disease control Sponsor: Zymeworks BC Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called ZW251 in about 100 people with advanced solid tumors, including liver cancer (hepatocellular carcinoma), a type of lung cancer (squamous cell non-small cell lung cancer), and germ cell tumors. ZW251 is an antibody-drug conjugate designed to deliver a cancer-killing agent directly to cells that have a protein called glypican-3 on their surface. The main goals are to check the drug's safety and find the right dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZW251 (an antibody-drug conjugate that targets a protein called glypican-3 on cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced liver, lung, or germ cell cancers that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial with only 100 participants, so the drug may not be effective or may cause serious side effects. It is too soon to know if it will help patients.
Why investors are watching

Zymeworks is testing ZW251, its first drug for people with advanced liver, lung, or germ cell cancers. This early-stage trial will show whether the drug is safe and can shrink tumors, and for a small company, that result can shape its entire pipeline value.

If it works: If ZW251 shows clear safety and signs of tumor control, Zymeworks could gain a stronger position in the cancer drug market and attract partnership interest. A positive readout would validate its technology platform beyond earlier programs.

If it fails: Phase 1 trials fail often, and ZW251 could prove too toxic or ineffective in people. A poor result would set the program back and could hurt the company's credibility with investors and partners.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

germ cell tumor hepatocellular carcinoma lung neoplasm Neoplasms, Germ Cell and Embryonal non-small cell lung carcinoma non-small cell squamous lung carcinoma squamous cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Germ cell tumor Hepatocellular carcinoma Squamous cell non small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Kansai Medical University Hospital

    RECRUITING

    Osaka, 573-1191, Japan

  • Kyoto University Hospital

    RECRUITING

    Kyoto, 606-8507, Japan

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

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

  • NEXT Oncology Madrid

    RECRUITING

    Madrid, 28223, Spain

  • National Cancer Center East

    RECRUITING

    Kashiwa, 2778577, Japan

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 104-0045, Japan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • START - Dublin Mater Misericordiae University Hospital (MMUH)

    RECRUITING

    Dublin, D07 R2WY, Ireland

  • START - Rioja Hospital Universitario San Pedro

    RECRUITING

    Logroño, 26006, Spain

  • START Barcelona

    RECRUITING

    Barcelona, 29010, Spain

  • START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

  • START Madrid Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • START Madrid Hospital Universitario HM Sanchinarro - CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • UCSF Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • Unidade Local de Saúde Gaia e Espinho

    RECRUITING

    Vila Nova de Gaia, 4434-502, Portugal

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

    RECRUITING

    Santa Monica, California, 90404, United States

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