Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS (NCT06846606) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS
United States34 participantsStarted 2025-05-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Participant must be ā„18 years of age
ā. Participant must have confirmed diagnosis as follows:
ā. Participant must be willing and able to comply with scheduled study visits and treatment plans.
ā. Participant must be willing to undergo all study procedures unless contraindicated due to medical risk.
ā. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ā¤2
ā. Participant must have adequate hepatic function
ā. Participant must have adequate renal function
ā. Participant must have adequate cardiovascular function
Exclusion criteria
ā. Participant is unable to provide informed consent and/or to follow protocol requirements.
ā. 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)
ā. Participant has another malignancy that may interfere with diagnosis and treatment of R/R AML or R/R MDS.
ā. Participant has an active severe infection that requires anti-infective therapy or has an unexplained temperature of \>38.5Ā°C during screening visits or on their first day of study treatment.
What they're measuring
1
Incidence of Adverse Events (AEs), Dose-Limiting Toxicities (DLTs), and Serious Adverse Events (SAEs)
Timeframe: From the first dose through 28 days after the last dose of study drug.