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Advanced CancerPhase 3NCT06174987

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

A Phase 3 study testing T-DXd in people with Advanced Cancer and Metastatic Cancer, run by Daiichi Sankyo at 34 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer
What is being tested?
T-DXd
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
34 sitesin 13 countries
Study dates
5 Jan 2024to 17 Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for enrollment into the study:
  • Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
  • No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
  • Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug.
  • If the participant is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug.
  • Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration.
  • Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout the Treatment Period in the compound-specific sub-protocol and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.

Who cannot join

  • Participants who meet any of the following criteria will be disqualified from entering the study:
  • Participants who permanently discontinued from the study drug in the parent study.
  • Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject.
  • Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.

Trial locations and contacts

34 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

34 sites in 13 countries

Turkey (Türkiye)6 sites

  • Research Facility

    Adana

    Active, not recruiting

  • Research Facility

    Ankara

    Active, not recruiting

  • Research Facility

    Antalya

    Active, not recruiting

  • Research Facility

    Diyarbakır

    Active, not recruiting

  • Research Facility

    Istanbul

    Active, not recruiting

  • Research Facility

    Tekirdağ

    Active, not recruiting

Other trials in Turkey (Türkiye)

France4 sites

  • Research Facility

    Lille

    Active, not recruiting

  • Research Facility

    Marseille

    Active, not recruiting

  • Research Facility

    Toulouse

    Active, not recruiting

  • Research Facility

    Villejuif

    Active, not recruiting

Other trials in France

Brazil3 sites

  • Research Facility

    Itajaí

    Active, not recruiting

  • Research Facility

    Rio de Janeiro

    Active, not recruiting

  • Research Facility

    São Paulo

    Active, not recruiting

Other trials in Brazil

China3 sites, 1 recruiting

  • Research Facility

    Changchun

    Active, not recruiting

  • Research Facility

    Harbin

    Active, not recruiting

  • Research Facility

    Hefei

    Recruiting

Other trials in China

Italy3 sites

  • Research Facility

    Aviano

    Active, not recruiting

  • Research Facility

    Milan

    Active, not recruiting

  • Research Facility

    Rozzano

    Active, not recruiting

Other trials in Italy

South Korea3 sites

  • Research Facility

    Daegu

    Active, not recruiting

  • Research Facility

    Goyang-si

    Active, not recruiting

  • Research Facility

    Seoul

    Active, not recruiting

Other trials in South Korea

Spain3 sites

  • Research Facility

    A Coruña

    Active, not recruiting

  • Research Facility

    Barcelona

    Active, not recruiting

  • Research Facility

    Madrid

    Active, not recruiting

Other trials in Spain

United States2 sites

  • Research Facility

    Durham, North Carolina, 27710

    Active, not recruiting

  • Research Facility

    Miami, Florida, 33176

    Active, not recruiting

Other trials in United States

Japan2 sites

  • Research Facility

    Chūōku

    Active, not recruiting

  • Research Facility

    Kashiwa-shi

    Active, not recruiting

Other trials in Japan

Taiwan2 sites

  • Research Facility

    Tainan

    Active, not recruiting

  • Research Facility

    Taipei

    Active, not recruiting

Other trials in Taiwan

Australia1 site

  • Research Facility

    Bedford Park

    Active, not recruiting

Other trials in Australia

Hong Kong1 site

  • Research Facility

    Hong Kong

    Active, not recruiting

Other trials in Hong Kong

Israel1 site

  • Research Facility

    Petah Tikva

    Active, not recruiting

Other trials in Israel

About this study

Official title: A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study.

Read the detailed description

This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.

Being tested
T-DXd
Keywords
Advanced cancer, Metastatic cancer, T-DXd, DS8201a
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-DXdDrug

    Also called DS8201a

    T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens

Study groups in NCT06174987
Study groupRoleWhat they receive
T-DXdExperimentalParticipants who choose to continue treatment with T-DXd may be enrolled. Participants who were on the comparator arm in the parent study will be provided the option to access the drug through standard of care (SoC) or other available options. Participants will remain on their current dosage regimen of T-DXd as the last dose administered in the parent study, unless they experience an AE that requires dose reduction at the EOT of the parent study, in which case the starting dose in this study will be the next lower dose-level.
Receives: Drug: T-DXd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs)

    Measured: Baseline until disease progression, loss of clinical benefit, death, adverse event, pregnancy, withdrawal of consent, access to commercial supply, physician decision, or study closure, whichever occurs first, up to approximately 2 years 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start5 Jan 2024
  3. Primary completion17 Feb 2028 (estimated)
  4. Study completion17 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Continued-access study
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06174987
Sponsor's protocol ID
ROMast-001
Other IDs
2023-506330-73-00, 2023
Status last verified
Oct 2026
First submitted
8 Dec 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T-DXd in people with Advanced Cancer and Metastatic Cancer, run by Daiichi Sankyo at 34 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Turkey (Türkiye), France, Brazil, China, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs) (time frame: Baseline until disease progression, loss of clinical benefit, death, adverse event, pregnancy, withdrawal of consent, access to commercial supply, physician decision, or study closure, whichever occurs first, up to approximately 2 years 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06174987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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