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New drug combo targets Hard-to-Treat HER2 cancers

NCT ID NCT05356741

Disease control Sponsor: Vir Biotechnology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new drug called VIR-5818, alone or combined with the immunotherapy pembrolizumab, in people with advanced HER2-expressing cancers that have not responded to standard treatments. The study will first find the safest dose, then expand to see if the drug shrinks tumors. About 645 participants are expected to join across multiple cancer types.

What this could mean

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

Active substance
VIR-5818 (an antibody-drug conjugate) and pembrolizumab (an immunotherapy)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced HER2-positive cancers that have stopped responding to other therapies.
What could go wrong
This is an early phase 1/2 trial, so the main goals are safety and dosing, not yet proving effectiveness. Side effects are unknown, and many early-stage cancer drugs do not advance to later trials.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 645 people

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

Started

Apr 2022

Expected to finish

Apr 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: * Written informed consent by the participant (or legally acceptable representative if applicable) * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests Exclusion criteria: * Significant cardiopulmonary disease and recent cardiac events * History of major organ autoimmune diseases * Acute or chronic infections The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

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As listed by the trial registrant

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

Locally advanced or metastatic HER2-expressing cancers

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

    11 sites in 5 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

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Investigational site number #100

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Investigational site number #101

    RECRUITING

    Randwick, 2031, Australia

  • Investigational site number #150

    RECRUITING

    Toulouse, 31059, France

  • Investigational site number #200

    RECRUITING

    Porto, 4200-072, Portugal

  • Investigational site number #250

    RECRUITING

    Pamplona, 31008, Spain

  • Investigational site number #251

    RECRUITING

    Barcelona, 08035, Spain

  • Investigational site number #252

    RECRUITING

    Madrid, 28050, Spain

  • Investigational site number #253

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Investigational site number #254

    RECRUITING

    Madrid, 28027, Spain

  • Investigational site number #255

    RECRUITING

    Barcelona, 08023, Spain

  • Investigational site number #257

    RECRUITING

    Madrid, Madrid, 28034, Spain