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Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML

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NCT04588922 · readout in 133 d

Sponsored by Sellas Life Sciences Group (industry) · SLS — their whole pipeline →.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
160estimated
Sites
26
Countries
China, 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
DateFiledBasisWhat it is
Start2021-05-10actualWhen the study began enrolling
Primary completion2026-12-30estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-12-31estimatedThe whole study's end, after follow-up
First posted2020-10-19actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Hematologic Malignancies

Interventions

  • Drug: SLS009 — also filed as GFH009
  • Drug: venetoclax — also filed as Venclexta
  • Drug: azacitidine — also filed as Vidaza, azacytidine

Primary outcomes

what the primary-completion date above is the date OF
Safety and Tolerability: Dose Limiting Toxicities (DLTs)
measured 21 to 28 days
Safety and Tolerability: adverse events (AEs)
measured approximately 2 years
Efficacy: ORR
measured 2 years

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