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NCT Number: NCT06174987

A 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 (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

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Key information

Conditions

Advanced Cancer Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Flinders Medical Center, Bedford Park, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-DXd

Drug

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

Other names: DS8201a

Primary outcomes

  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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

[email protected]

908-992-6400

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 18, 2023
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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