First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
← catalyst calendarNCT03401385 · readout in 135 d
Sponsored by Daiichi Sankyo Co., Ltd. (industry) · 4568.T — their whole pipeline →. With Daiichi Sankyo, AstraZeneca.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
890estimated
Sites
18
Countries
Japan, United States
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 | 2018-01-31 | actual | When the study began enrolling |
| Primary completion | 2027-01-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-01 | estimated | The whole study's end, after follow-up |
| First posted | 2018-01-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hormone Receptor Positive Breast Cancer
- Triple Negative Breast Cancer
- Non-small Cell Lung Cancer
Interventions
- Drug: Datopotamab Deruxtecan (Dato-DXd) — also filed as DS1062a, Study treatment
- Drug: Steroid Containing Mouthwash
- Other: Non-Steroid Containing Mouthwash
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with dose-limiting toxicities
measured Within 8 cycles (each cycle is 21 days)
Number of participants with adverse events (AEs)
measured When all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)
Number of participants with Grade >/= 2 oral mucositis/stomatitis in Sub-Study
measured At 8 weeks
Publications
- PMID 38652877 — linked by the registry
- PMID 38502995 — linked by the registry
- PMID 37327461 — 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.
Permalink · 4568.T's whole pipeline · Catalyst calendar · Every registered study · What changed