A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
← catalyst calendarNCT06244485 · readout in 805 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
98actual
Sites
35
Countries
China, Italy, Japan +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 | 2024-02-16 | actual | When the study began enrolling |
| Primary completion | 2028-11-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-11-01 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-21 | 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: Valemetostat tosylate — also filed as DS-3201b
- Drug: T-DXd — also filed as DS-8201a, ENHERTU
- Drug: Dato-DXd — also filed as DS-1062a
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants Reporting Dose-limiting Toxicities (Part 1 Dose Escalation)
measured Cycle 1 Day 1 up to Day 21 (each cycle is 21 days)
Number of Participants Reporting Treatment-emergent Adverse Events (Part 1 Dose Escalation)
measured Screening up to 40 days after last dose
Objective Response Rate Based on Investigator Assessment (Part 2 Dose Expansion)
measured Baseline (Screening), at every 6 weeks from Cycle 1 Day 1 in the first year, and every 12 weeks thereafter until disease progression or until the start of a new anticancer treatment, up to approximately 5 years
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