A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
← catalyst calendarSponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
50estimated
Sites
28
Countries
Australia, Belgium, Brazil +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-01-05 | actual | When the study began enrolling |
| Primary completion | 2026-08-03 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-01-17 | estimated | The whole study's end, after follow-up |
| First posted | 2023-12-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Cancer
- Metastatic Cancer
Intervention
- Drug: T-DXd — also filed as DS8201a
Primary outcome
what the primary-completion date above is the date OFNumber 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
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