A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
22actual
Sites
9
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 | 2023-04-17 | actual | When the study began enrolling |
| Primary completion | 2026-01-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-26 | actual | The whole study's end, after follow-up |
| First posted | 2023-02-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Solid Tumor
Intervention
- Drug: SAIL66
Primary outcomes
what the primary-completion date above is the date OFAdverse events of SAIL66[safety and tolerability]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Change from baseline in vital signs[safety and tolerability]
measured From screening until study completion or treatment discontinuation (approximately 18 weeks)
Change from baseline in clinical laboratory test results and examination findings[safety and tolerability]
measured From screening until study completion or treatment discontinuation (approximately 18 weeks)
Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]
measured From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
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