Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
← catalyst calendarNCT04145622 · readout in 254 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
250estimated
Sites
28
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 | 2019-11-03 | actual | When the study began enrolling |
| Primary completion | 2027-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-10-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-29 | 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
- Malignant Solid Tumor
Intervention
- Drug: Ifinatamab deruxtecan (I-DXd)
Primary outcomes
what the primary-completion date above is the date OFEvaluate the incidence of dose-limiting toxicities (DLTs)
measured Day 1 to Day 21 in Cycle 1 in the dose escalation part
Evaluate the incidence of adverse events (AEs)
measured Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)
measured Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Publications
- PMID 41926962 — 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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