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

ConditionsAML, AdultMDS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStelexis BioSciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eganelisib

    Drug

    eganelisib will be administered as monotherapy

  • Eganelisib in combination with cytarabine

    Drug

    eganelisib will be administered in combination with cytarabine

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: EganelisibExperimental treatment 1 intervention
Group B: Eganelisib in combination with cytarabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1

Time frame
28-35 days
3

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 outcomes

1

Area under the plasma concentration time curve extrapolated to the last measurable time point [AUClast] of eganelisib and cytarabine

Time frame
112 days
2

Maximum concentration [Cmax] of eganelisib and cytarabine

Time frame
112 days
3

Time of maximum concentration [Tmax] of eganelisib and cytarabine

Time frame
112 days
4

Plasma half-life [t1/2] of eganelisib and cytarabine

Time frame
112 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stelexis BioSciences

Lead sponsor

Source ClinicalTrials.gov
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