Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
← catalyst calendarNCT03850574 · readout ≤ 102 d
Sponsored by Aptose Biosciences Inc. (industry) · APTOF — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
240estimated
Sites
34
Countries
Australia, Germany, New Zealand +3
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 | 2019-03-11 | actual | When the study began enrolling |
| Primary completion | Nov 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2019-02-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Leukemia, Myeloid, Acute
- Refractory AML
- Relapsed Adult AML
- Myelodysplastic Syndrome With Excess Blasts-2
- Chronic Myelomonocytic Leukemia
Interventions
- Drug: Tuspetinib — also filed as HM43239
- Drug: Venetoclax Oral Tablet — also filed as Venetoclax
- Drug: Azacitidine for Intravenous Infusion — also filed as Azacitidine
Primary outcomes
what the primary-completion date above is the date OFFrequency and severity of drug-related adverse events
measured 4 years
Maximum tolerated dose (MTD) of tuspetinib
measured 4 years
Maximum plasma concentration (Cmax)
measured Cycle 1 (at least 28 days)
Minimum plasma concentration (Cmin)
measured Cycle 1 (at least 28 days)
Area under the plasma concentration-time curve (AUC)
measured Cycle 1 (at least 28 days)
Time to maximum concentration (Tmax)
measured Cycle 1 (at least 28 days)
Terminal half-life (t1/2)
measured Cycle 1 (at least 28 days)
Volume of distribution
measured Cycle 1 (at least 28 days)
Plasma clearance (CL)
measured Cycle 1 (at least 28 days)
Recommended Phase 2 dose (RP2D) of tuspetinib
measured 4 years
Publications
- PMID 39665627 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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