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

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• Any of the following within the specified time frame: -Prior systemic cancer therapy is allowed regardless of the stop date, but the patient must have recovered to eligibility levels from prior toxicity. --> Hydroxyurea is allowed for patients with rapidly proliferative disease for peripheral blast control, up to Cycle 1 Day 7. - Major surgery within 28 days prior to Cycle 1 Day 1. - Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1. - Receiving immunosuppressants (eg, cyclosporin or calcineurin inhibitors) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency or low-dose steroids with a maximum of an equivalent of 10 mg prednisone/day) within 28 days prior to Cycle 1 Day 1. - 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. - Active graft-versus-host disease (GVHD) after allogeneic stem cell transplantation, or chronic GVHD requiring systemic steroid administration. - Current use (including within 5 half-lives) of an investigational agent.
• History or current evidence of any acute or chronic condition, therapy, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or might confound the results of the trial, interfere with participation for the full duration of the trial, or render trial participation not compatible with the patient’s best interest, in the opinion of the Investigator.
• Administration of any of the following within 14 days prior to the first dose of eganelisib and for the study duration: - Moderate or strong inhibitors or inducers of CYP2C8 and CYP3A4, including grapefruit, grapefruit juice, Seville oranges, St. John’s wort and herbal supplements, except for antibiotics, antifungals, or antivirals that are moderate or strong inhibitors of CYP3A if they cannot be avoided. - P-glycoprotein (P-gp) inhibitors, except for antibiotics, antifungals, or antivirals if they cannot be avoided. - Breast cancer resistance protein (BCRP) inhibitors.
• Administration of any of the following as of Cycle 1 Day 1 and for the study duration: - P-gp substrates with a narrow therapeutic index. - Warfarin, phenytoin, or other CYP2C8 or CYP2C9 substrates with a narrow therapeutic index.
• Corrected QT with Fridericia’s method (QTcF) interval on screening electrocardiogram (ECG) ≥450 msec for males and ≥470 msec for females, except for patients with atrioventricular pacemakers or other conditions (eg, right bundle branch block) that render the QT measurement invalid.
• 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).