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Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS

NCT06846606 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Relapsed Acute Myeloid Leukemia (AML)
  • Refractory Acute Myeloid Leukemia (AML)
  • Relapsed/Refractory AML
  • Relapsed Myelodysplastic Syndromes
  • Refractory Myelodysplastic Syndromes
  • Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Interventions

DRUG

AUTX-703

AUTX-703 administered orally

Sponsors & Collaborators

  • Auron Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-04-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846606 on ClinicalTrials.gov