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New drug ZW191 targets Hard-to-Treat cancers in early trial

NCT ID NCT06555744

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called ZW191 in people with advanced solid tumors, including ovarian, endometrial, and non-small cell lung cancers. The drug is designed to target a protein on cancer cells and deliver a toxic payload. The main goals are to check safety, find the right dose, and see if it shrinks tumors.

Why investors are watching

Zymeworks is testing ZW191, an antibody drug conjugate that targets a protein called folate receptor alpha, in 145 people with advanced ovarian, endometrial, and non-small cell lung cancers. For a small company, this phase 1 trial is a key test of whether the drug is safe and shows early signs of shrinking tumors, which could determine the value of its pipeline.

If it works: If ZW191 proves safe and shows anti-tumor activity in these hard-to-treat cancers, Zymeworks could advance the drug to later-stage trials and strengthen its position as a developer of targeted cancer therapies.

If it fails: Phase 1 trials often fail because the drug proves too toxic or lacks clear benefit. A poor safety profile or weak tumor response could force Zymeworks to abandon ZW191, leaving the company with fewer pipeline assets and a longer path to revenue.

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 145 people

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

Started

Oct 2024

Expected to finish

Jan 2027

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 cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease. * Measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA). * Other adequate organ function. Exclusion Criteria: * Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints. * Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period. * Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease. * Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Clínica Universidad de Navarra

    Madrid, 28027, Spain

  • Curie Oncology

    Singapore, 217562, Singapore

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009, Spain

  • Gangnam Severance Hospital

    Seoul, 6273, South Korea

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Linear Clinical Research

    Nedlands, WA 6009, Australia

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • NEXT Oncology Madrid

    Madrid, 28223, Spain

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)

    Singapore, 119228, Singapore

  • Royal North Shore Hospital Northern Sydney Cancer Centre

    St Leonards, NSW 2065, Australia

  • Saitama Medical University International Medical Center

    Saitama, 350-1298, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

    Columbus, Ohio, 43210, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.