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Continued Access to T-DXd for Advanced Cancer

This study offers continued treatment with T-DXd (DS8201a) for people with advanced or metastatic cancer who are already benefiting from this drug in a previous Daiichi Sankyo or Daiichi Sankyo/AstraZeneca study. T-DXd is given through an IV (into a vein) infusion every 21 days. The main goal is to track any side effects that lead to stopping the drug, reducing the dose, or serious side effects over time. You can join if you are 18 or older, have signed an informed consent form, and are currently enrolled in a specific parent study with no signs of your cancer getting worse. The study aims to enroll 50 participants.

Study design
This is an open-label, multicenter study without a specified phase, designed to provide continued treatment. It plans to enroll 50 participants.
What's involved
T-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle. The study will continue until disease progression, loss of clinical benefit, death, or other reasons, for up to approximately 2 years and 9 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from 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 and 9 months.

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NCT06174987

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Daiichi Sankyo
~50 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:T-DXd

At a glance

Recruiting sites
15 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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 over 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

Conditions

Advanced Cancer
Metastatic Cancer

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Where it's being run

28 sites across 13 states
South Korea7
Spain5
Brazil3
Australia2
Italy2
Taiwan2
Florida1
North Carolina1

Study leadership

  • Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo

Who to contact

Daiichi Sankyo Contact for Clinical Trial Information
[email protected]
908-992-6400
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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)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