Eganelisib + Cytarabine for AML

Recruiting at 4 trial locations

Overseen By Clinical Trials Office Stelexis

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stelexis BioSciences

Must not be taking: Immunosuppressants, Systemic steroids

Disqualifiers: Stem cell transplant, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

Trial Summary

What is the purpose of 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

Research Team

Mieke Ptaszynski, MD

Principal Investigator

Stelexis BioSciences

Eligibility Criteria

This trial is for adults with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes. Participants must have an ECOG performance status of ≤2, indicating they can perform daily activities with some limitations, and proper liver and kidney function. Those with certain types of AML or less than 10% bone marrow blasts are excluded.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

I have been diagnosed with a specific type of blood cancer, not including acute promyelocytic leukemia, but possibly secondary or treatment-related AML, or high-risk myelodysplastic syndromes.

My liver and kidney functions are within normal ranges.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of eganelisib as monotherapy and in combination with cytarabine to evaluate safety and tolerability

8-12 weeks

Dose Optimization

Participants receive optimized doses of eganelisib and cytarabine to further assess safety and anti-tumor efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cytarabine
• Eganelisib

Trial Overview The study tests Eganelisib alone and combined with Cytarabine in two parts: dose escalation to find a safe amount, followed by dose optimization to determine the best therapeutic level. It aims to assess safety, tolerability, how the body processes the drugs (PK), their effects on the disease (PD), and effectiveness against tumors.

Participant Groups

Group I: Eganelisib in combination with cytarabine Experimental Treatment 1 Intervention

Group II: Eganelisib Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stelexis BioSciences

Lead Sponsor

Trials

1

Recruited

130+