A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
← catalyst calendarNCT07770698 · readout in 1,350 d
Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.
Phase
Phase 1/2
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
30estimated
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 | Oct 2026 | estimated | When the study began enrolling |
| Primary completion | 2030-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsed Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- B-cell Acute Lymphoblastic Leukemia
- Pediatric Cancer
- Pediatric ALL, Relapsed
- Pediatric ALL
- Pediatric ALL, B Cell
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Pediatric AML
- R/R AML
- R/R B-cell ALL
Interventions
- Drug: sonrotoclax — also filed as BGB-11417
- Drug: Azacitidine
- Drug: Inotuzumab ozogamicin — also filed as Besponsa
- Drug: Dexamethasone
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured From first dose of study drug to 30 days after last dose; up to approximately 12 months in cohort 1 and 4 months in cohort 2.
Part 1: Recommended Dose for Expansion (RDFE) of Sonrotoclax
measured From first dose through end of Cycle 1 (each cycle is 28 days); approximately 2 months
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