S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
← catalyst calendarNCT05101070 · readout in 650 d
Sponsored by Shionogi (industry) · 4507.T — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
282estimated
Sites
8
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 | 2022-05-30 | actual | When the study began enrolling |
| Primary completion | 2028-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Solid Tumors
Interventions
- Drug: S-531011
- Drug: Pembrolizumab — also filed as KEYTRUDA
- Drug: Bevacizumab — also filed as Avastin
Primary outcomes
what the primary-completion date above is the date OFPart A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
measured Approximately 12 months (Part A-1); Approximately 24 months (Part A-2)
Parts B, C, D, E: Objective Response Rate
measured Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Duration of Response
measured Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Disease Control Rate
measured Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Time to Response
measured Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Progression-free Survival
measured Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Overall Survival
measured Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
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