DS-3201b in Participants With Lymphomas
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
100estimated
Sites
20
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 | 2016-03-31 | actual | When the study began enrolling |
| Primary completion | 2022-12-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2016-04-08 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Lymphoma, Malignant
- Non-hodgkin Lymphoma
Interventions
- Drug: DS-3201b
- Drug: DS-3201b
Primary outcomes
what the primary-completion date above is the date OFDose Escalation Period: Number of participants with dose-limiting toxicities (DLTs)
measured within 28 days after the initial dose of the study drug
Dose Escalation Period: Maximum concentration (Cmax) of DS-3201
measured within the first 28-day cycle
Dose Escalation Period: Time of maximum concentration (Tmax) of DS-3201
measured within the first 28-day cycle
Dose Escalation Period: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201
measured Day 1 of the first 28-day cycle
Dose Escalation Period: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201
measured Day 1 of the first 28-day cycle
Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough)
measured Day 15 of the first 28-day cycle
Dose Escalation Period: Average plasma concentration (Cavg)
measured Day 15 of the first 28-day cycle
DDI cohort only: Maximum concentration (Cmax) of DS-3201, midazolam, digoxin
measured within the first 28-day cycle
DDI cohort only: Time of maximum concentration (Tmax) of DS-3201, midazolam, digoxin
measured within the first 28-day cycle
DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin
measured within the first 28-day cycle
DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin
measured within the first 28-day cycle
Number of participants with treatment-emergent adverse events (TEAEs)
measured through the end of the study (within approximately 5 years)
Publications
- PMID 41258689 — linked by the registry
- PMID 41150706 — linked by the registry
- PMID 39486432 — 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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