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Cancer drug T-DXd safety tracked in ongoing rollover study

NCT ID NCT06174987

Disease control Sponsor: Daiichi Sankyo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study offers continued access to the cancer drug T-DXd for up to 50 people with advanced or metastatic cancer who are already benefiting from it in earlier trials. Researchers will monitor long-term safety, including serious side effects and reasons for stopping or reducing the drug. The goal is to ensure the treatment remains safe over time.

What this could mean

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

Active substance
T-DXd (trastuzumab deruxtecan)
What this could lead to
If successful, this study could confirm that long-term use of T-DXd is safe for people with advanced cancer, supporting its continued use as a treatment option.
What could go wrong
This is a small, open-label rollover study (50 participants) focused on safety, not on proving effectiveness. It may not detect rare side effects or apply to all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 50 people

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

Started

Jan 2024

Expected to finish

Jan 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: * Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements. * Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. * No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). Exclusion Criteria: * Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria * Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Advanced cancer Metastatic 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

    19 sites in 8 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

  • A.C. Camargo Cancer Center

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Duke University - Trent Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Flinders Medical Center

    ACTIVE_NOT_RECRUITING

    Bedford Park, 5042, Australia

  • Grand Hôpital de Charleroi

    RECRUITING

    Charleroi, 6000, Belgium

  • Hospital Ruber Internacional

    WITHDRAWN

    Madrid, 28034, Spain

  • Hospital Universitari Dexeus

    NOT_YET_RECRUITING

    Distrito de Les Corts, 08028, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • IBCC Nucleo de Pequisa e Ensino

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • ICO l'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Instituto Aericas

    NOT_YET_RECRUITING

    Rio de Janeiro, Brazil

  • Istituto Nazionale Tumori Fondazione G. Pascale

    WITHDRAWN

    Naples, 80131, Italy

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, 41404, South Korea

  • Miami Cancer Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Monash Medical Center

    WITHDRAWN

    Melbourne, 3168, Australia

  • National Cancer Center

    RECRUITING

    Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Chūō, 104-0045, Japan

  • National Cheng Kung University Hospital

    WITHDRAWN

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    WITHDRAWN

    Taipei, 10002, Taiwan

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Rabin Medical Center

    ACTIVE_NOT_RECRUITING

    Petah Tikva, Israel

  • Royal Surrey County Hospital

    WITHDRAWN

    Guildford, GU2 7XX, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    WITHDRAWN

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Jongno-gu, 03080, South Korea

  • Severance Hospital, Yonsei University

    RECRUITING

    Seoul, 03722, South Korea

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