This Phase 1, multicenter, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AUTX-703 administered orally in subjects with advanced hematologic malignancies.
Participant must be ≥18 years of age
Participant must be willing and able to comply with scheduled study visits and treatment plans.
Participant must be willing to undergo all study procedures unless contraindicated due to medical risk.
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Participant is unable to provide informed consent and/or to follow protocol requirements.
Participant has undergone chimeric antigen receptor T cell therapy or HSCT within 60 days of the first dose of study treatment or has active clinically significant graft-versus-host disease (GVHD)
Participant has another malignancy that may interfere with diagnosis and treatment of R/R AML or R/R MDS.
Participant has an active severe infection that requires anti-infective therapy or has an unexplained temperature of >38.5°C during screening visits or on their first day of study treatment.
Sequential
AUTX-703
DrugAUTX-703 administered orally
Incidence of Adverse Events (AEs), Dose-Limiting Toxicities (DLTs), and Serious Adverse Events (SAEs)
To assess the safety and tolerability of AUTX-703 by evaluating the incidence and severity of AEs, DLTs, SAEs, and AEs leading to treatment discontinuation.
To Identify the Recommended Phase 2 Dose (RP2D) of AUTX-703
To determine the RP2D of AUTX-703 based on safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity data.
Peak Plasma Concentration (Cmax)
Time to Maximum Concentration (Tmax)
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf)
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