RECRUITING

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

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Conditions

Relapsed Acute Myeloid Leukemia (AML)Refractory Acute Myeloid Leukemia (AML)Relapsed/Refractory AMLRelapsed Myelodysplastic SyndromesRefractory Myelodysplastic SyndromesRelapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)AUTX-703Relapsed Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaAcute Myeloid LeukemiaKAT2A/B degraderMyelodysplastic Syndromes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study of AUTX-703 in Participants With Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes

Quick Facts

Study Start:2025-04
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06846606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant must be ≥18 years of age
  2. 2. Participant must have confirmed diagnosis as follows:
  3. 3. Participant must be willing and able to comply with scheduled study visits and treatment plans.
  4. 4. Participant must be willing to undergo all study procedures unless contraindicated due to medical risk.
  5. 5. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
  6. 6. Participant must have adequate hepatic function
  7. 7. Participant must have adequate renal function
  8. 8. Participant must have adequate cardiovascular function
  9. 9. Participant must have a white blood cell (WBC) count ≤20 × 10⁹/L (with stable hydroxyurea use allowed)
  10. 10. Participant must meet timing requirements with respect to prior therapy and surgery
  11. 11. Participant must agree to use effective contraception during the study and for the required post-treatment period: Males: Use condoms (even if vasectomized) during the study and for 90 days post-treatment. Females of childbearing potential: Use a combination of 1 highly effective and 1 effective method of contraception during the study and for 180 days post-treatment.
  1. 1. Participant is unable to provide informed consent and/or to follow protocol requirements.
  2. 2. 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)
  3. 3. Participant has another malignancy that may interfere with diagnosis and treatment of R/R AML or R/R MDS.
  4. 4. 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.
  5. 5. Participant has a known sensitivity to AUTX-703 or any of its components.
  6. 6. Participant is taking systemic strong CYP3A4 inhibitors or inducers within 14 days of the first dose of study treatment.
  7. 7. Participant who are taking proton pump inhibitors should be switched to another acid-reducing agent such as an antacid or H2 blocker
  8. 8. Participant is taking P-gp and breast cancer resistance protein (BCRP) inhibitors or inducers within 14 days of first dose of study treatment.
  9. 9. Participant has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections with detectable viral load
  10. 10. Participant has experienced AIDS related illness within the past 6 months or have detectable HIV viral load.
  11. 11. Participant has an uncontrolled intercurrent illness
  12. 12. Participant has active Class III or IV cardiovascular disease within 6 months prior to the start of study treatment
  13. 13. Participant is unable to tolerate the administration of oral medication or has GI dysfunction that would preclude adequate absorption, distribution, metabolism, or excretion of an oral medication
  14. 14. Participant is pregnant or breastfeeding or is planning to become pregnant within 1 year of the start of study treatment

Contacts and Locations

Study Contact

Auron Clinical Trials
CONTACT
617-514-2356
clinicaltrials@aurontx.com

Study Locations (Sites)

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: Auron Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-04
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • AUTX-703
  • Relapsed Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia
  • Relapsed/Refractory AML
  • Acute Myeloid Leukemia
  • Relapsed Myelodysplastic Syndromes
  • Refractory Myelodysplastic Syndromes
  • KAT2A/B degrader
  • Myelodysplastic Syndromes

Additional Relevant MeSH Terms

  • 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)