Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 15, 2027 → Dec 15, 2027
Primary endpoint removed 3 → 2 primary endpoints
Enrollment reduced 16% 125 → 105 participants
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Record History

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  1. Primary endpoint(s) modified Show 9 more changesShow less
    • Primary completion pushed from Jul 15, 2027 to Dec 15, 2027
    • Enrollment reduced: 125 → 105 participants
    • Study completion pushed from Mar 15, 2028 to Sep 15, 2028
    • Interventions modified
    • Trial arms changed: 2 → 4
    • Study sites: 13 to 12
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: 5 to 6
    • Study title expanded, about 9 words
  2. Site contacts updated at 1 of 13 sitesv9
  3. Study sites: 10 to 13v8
  4. Site details revised at 3 of 10 sitesv7
  5. Study sites: 4 to 10v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 4v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2025 to Apr 28, 2025
    • Study sites: 0 to 1
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Eligibility criteria revisedv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1b open-label, multicenter, dose-escalation and randomized combination cohort study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS) and in combination with azacitidine in PI3K-Gamma-Positive patients with previously untreated HR-MDS. The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination with cytarabine. * Part 2: Randomized Combination Cohort: eganelisib + azacitidine and azacitidine alone
Trial Details
NCT Number NCT06533761
Lead Sponsor Stelexis BioSciences
Conditions
(from sponsor)		 AML, Adult, MDS
Related terms Leukemia, Myeloid, Acute
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov