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Recruiting NCT06533761

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

Phase I Interventional AML, Adult MDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eganelisib, Eganelisib in combination with cytarabine.
Who it may be relevant to
Registry conditions: AML, Adult, MDS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Overview

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

Interventions

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

Primary outcome measures

  • 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]
  • Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1 [Time frame: 28-35 days]
  • Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS [Time frame: 12 months]
Secondary outcome measures (5)
  • Area under the plasma concentration time curve extrapolated to the last measurable time point [AUClast] of eganelisib and cytarabine [Time frame: 112 days]
  • Maximum concentration [Cmax] of eganelisib and cytarabine [Time frame: 112 days]
  • Time of maximum concentration [Tmax] of eganelisib and cytarabine [Time frame: 112 days]
  • Plasma half-life [t1/2] of eganelisib and cytarabine [Time frame: 112 days]
  • Measure plasma concentrations of eganelisib and determine model-based PK parameters [Time frame: 112 days]

Eligibility criteria

Inclusion criteria

  • Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.

Exclusion criteria

  • Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.
  • Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).
  • Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for >72 hours prior to treatment
  • WBC count >25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
  • Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • City of Hope — Duarte
  • Anshutz Cancer Pavilion — Aurora
  • Moffitt Cancer Center — Tampa
  • Dana-Farber Cancer Institute — Boston
  • Washington University in St Louis — St Louis
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Cancer Center — New York
  • Montefiore Medical Center — New York
  • … and 3 more centers
Spain · 2 centers
  • Hospital San Pedro de Alcántara — Cáceres
  • Hospital Universitari i Politècnic La Fe — Valencia

Identifiers

NCT: NCT06533761 · STLX-EGA-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗