Study of AUBE00 in Patients With Solid Tumors
← catalyst calendarNCT07030959 · readout in 1,230 d
Sponsored by Chugai Pharmaceutical (industry) · 4519.T — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
130estimated
Sites
4
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 | 2025-06-05 | actual | When the study began enrolling |
| Primary completion | 2029-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | 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: AUBE00
- Drug: Cetuximab
Primary outcomes
what the primary-completion date above is the date OFAdverse events of AUBE00 [Part A, B, C]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Number of participants with changes in vital signs of AUBE00 [Part A, B, C]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Maximum tolerated dose (MTD) of AUBE00 [Part A, C]
measured From Cycle 0 Day 1 until Cycle 2 Day 1 (approximately 30 days) (Cycle 0: 6 to 9 days, Cycle 1 and beyond each Cycle: 21 days) [Part A]; From Cycle 1 Day 1 until Cycle 2 Day 1 (approximately 28 days) (Cycle 1 and beyond each Cycle: 28 days) [Part C]
Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part A]
measured From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Maximum plasma concentration (Cmax) of AUBE00 [Part A]
measured From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Elimination half-life (t1/2) of AUBE00 [Part A]
measured From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Area under the plasma concentration-time curve (AUC) of AUBE00 [Part A]
measured From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Objective response of AUBE00 [Part B, C]
measured From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
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