Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
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Phase
Phase 1/2
Status
Suspended
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
366estimated
Sites
32
Countries
Czechia, France, Germany +5
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
Why the sponsor stopped it
Dosing completed in all cohorts. Planning underway for potential additional patient cohorts.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-07-06 | actual | When the study began enrolling |
| Primary completion | 2026-04-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-01 | estimated | The whole study's end, after follow-up |
| First posted | 2020-02-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
Interventions
- Drug: Emavusertib — also filed as CA-4948
- Drug: Venetoclax
- Drug: Emavusertib — also filed as CA-4948
Primary outcomes
what the primary-completion date above is the date OFDetermine Maximum Tolerated Dose (MTD) of emavusertib (CA-4948) monotherapy (Phase 1)
measured 28 days
Determine the Recommended Phase 2 Dose (RP2D) of emavusertib monotherapy (Phase 1)
measured 24 months
Determine Maximum Tolerated Dose (MTD) of emavusertib in combination with venetoclax (Phase 1b)
measured 28 days
Determine the Recommended Phase 2 Dose (RP2D) of emavusertib in combination with venetoclax (Phase 1b)
measured 24 months
To assess anti-cancer activity (Phase 2a - AML patients)
measured 24 months
To assess anti-cancer activity (Phase 2a - hrMDS patients)
measured 24 months
To assess safety (Phase 1b)
measured 24 months
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