A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
← catalyst calendarNCT05765851 · readout in 1,364 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
108estimated
Sites
8
Countries
Canada, France, Spain +1
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 | 2023-05-30 | actual | When the study began enrolling |
| Primary completion | 2030-05-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-05-15 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-28 | 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 Tumor
Interventions
- Drug: DS-1103a
- Drug: T-DXd — also filed as DS-8201a (trastuzumab derextecan), Enhertu®
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Dose-limiting Toxicities (Dose Escalation)
measured From Cycle 1 Day 1 to Cycle 2 Day 21 (each cycle is 21 days)
Number of Participants with Dose-limiting Toxicities Following DS-1103a Combination Therapy (Dose Expansion; Cohort 2)
measured From Cycle 1 Day 1 to Cycle 1 Day 21 (each cycle is 21 days)
Overall Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Dose Escalation and Dose Expansion)
measured Screening through long-term follow up, up to approximately 91 months
Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion)
measured Baseline (Dose Expansion) up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years 11 months
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