Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Part of paid clinical trials in Duarte, California.

Sponsor
Stelexis BioSciences
Study ID
NCT06533761
Phase
PHASE1
Status
Recruiting
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Conditions

  • AML, Adult
  • MDS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Eganelisib — DRUG
    eganelisib will be administered as monotherapy
  • Eganelisib in combination with cytarabine — DRUG
    eganelisib will be administered in combination with cytarabine

Study Details

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization 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). The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination. * Part 2: Dose Optimization

Key Dates

Start date
Apr 28, 2025
Status verified
Oct 2025
Primary completion
Jul 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Eganelisib
  • Experimental: Eganelisib in combination with cytarabine

Primary Outcome Measure

Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 [ Time Frame: 12 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Shukaib Arslan
[email protected]
626-218-1133
Anshutz Cancer PavilionAuroraColorado80045
Moffitt Cancer CenterTampaFlorida33612
Wes Mungal
[email protected]
813-745-0851
Dana-Farber Cancer InstituteBostonMassachusetts02215
Megan Forsyth
[email protected]
857-215-1405
Washington University in St LouisSt LouisMissouri63110
Na'kie Coleman-Elhasan
[email protected]
314-454-8708
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Anmol Shah
[email protected]
646-608-2813
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Anmol Shah
[email protected]
646-608-2813
Montefiore Medical CenterNew YorkNew York10466
Davina Hoban
[email protected]
201-618-4725
Cleveland ClinicClevelandOhio44106
Ibraheem Al-Aref
[email protected]
216-442-0461
Ohio State UniversityColumbusOhio43210
Sarah Mayne
[email protected]
614-685-9573
MD Anderson Cancer CenterHoustonTexas77054
Meagan Sachs
[email protected]
713-503-1589

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAAnshutz Cancer Pavilion· Aurora, COMoffitt Cancer Center· Tampa, FLDana-Farber Cancer Institute· Boston, MAWashington University in St Louis· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NY

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