Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for HER2 cancers: first human trial launches

NCT ID NCT05523947

Disease control Sponsor: Yuhan Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This early-phase trial tests an experimental drug called YH32367 in people with HER2-positive solid tumors that have spread or cannot be removed by surgery. The study has two parts: first, finding a safe dose, then testing that dose in specific cancer types like biliary tract cancer. About 147 participants will be enrolled to check safety, how the drug moves through the body, and whether it shrinks tumors.

What this could mean

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

Active substance
YH32367 (an experimental drug)
What this could lead to
If successful, this could point toward a new treatment option for people with HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early first-in-human study, so safety and effectiveness are not yet known. The drug may not shrink tumors or could cause unexpected side effects.

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 147 people

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

Started

Aug 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: \[Dose Escalation Part\] * Pathologically confirmed HER2-positive * Mandatory provision of tumor tissue sample \[Dose Expansion Part\] * Patients who have at least one measurable lesion * Mandatory provision of tumor tissue sample 1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer 2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer Exclusion Criteria: * Uncontrolled central nervous system (CNS) metastases * Spinal cord compression * Carcinomatous meningitis * Acute coronary syndromes * Heart failure * Interstitial lung disease (ILD) * Pneumonitis * History of a second primary cancer * Human immunodeficiency virus (HIV) * Active chronic hepatitis B * Hepatitis C * Systemic steroid therapy * Autoimmune disease

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HER2 positive solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms breast neoplasm gastric neoplasm

As listed by the trial registrant

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

HER2 positive solid tumor

How to take part

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

  1. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Ajou University Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Austin Health

    WITHDRAWN

    Melbourne, Australia

  • Blacktown Hospital

    RECRUITING

    Sydney, Australia

  • Breast Cancer Research Centre - WA

    WITHDRAWN

    Perth, Australia

  • CHA Bundang Medical Center

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Catholic University of Korea St. Vincent's Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 16247, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Gachon Gil University Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gyeongsang National University Hospital

    RECRUITING

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02841, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Southern Oncology Clinical Research Unit

    TERMINATED

    Adelaide, Australia

  • The Catholic University of Korea, St. Mary's hospital

    RECRUITING

    Seoul, 06591, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, 44437, South Korea

  • Vanderbilt Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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