A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
← catalyst calendarNCT06172478 · readout in 378 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
740estimated
Sites
85
Countries
Australia, Belgium, Canada +13
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 | 2024-02-26 | actual | When the study began enrolling |
| Primary completion | 2027-09-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-10-10 | estimated | The whole study's end, after follow-up |
| First posted | 2023-12-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumor
- Melanoma
- Head and Neck Cancer
- Gastric Cancer
- Ovarian Carcinoma
- Cervical Cancer
- Endometrial Cancer
- Bladder Cancer
- Esophageal Cancer
- Pancreatic Carcinoma
- Prostate Cancer
- Non-small Cell Lung Cancer (NSCLC)
- Lung Cancer
- Breast Cancer
Intervention
- Drug: HER3-DXd — also filed as Patritumab Deruxtecan, U3-1402
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)
measured Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months
Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only)
measured Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months
Publications
- PMID 41088723 — 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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