A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
102actual
Sites
30
Countries
Belgium, Canada, Denmark +6
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 | 2020-12-30 | actual | When the study began enrolling |
| Primary completion | 2023-01-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-14 | estimated | The whole study's end, after follow-up |
| First posted | 2020-11-20 | actual | When this record first appeared on the registry |
| Results posted | 2024-02-15 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
Intervention
- Drug: Trastuzumab deruxtecan — also filed as DS-8201a (T-DXd)
Primary outcome
what the primary-completion date above is the date OFConfirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR)
measured Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-07-20 · 1.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-02-07 · 785 KB · SAP_001.pdf
Publications
- PMID 38710187 — linked by the registry
- PMID 37597578 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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