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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be ≥18 years of age

• Participant must have confirmed diagnosis as follows:

• R/R AML and has not achieved adequate response to, cannot tolerate, or refused all approved therapies known to be active for treatment of their disease OR R/R MDS with over 10% blasts in the bone marrow and has not achieved an adequate response to at least 4 cycles of a hypomethylating agent (HMA)- containing regimen or other treatment known to be active for their disease OR R/R AML or R/R MDS that has relapsed after a hematopoietic stem cell transplant (HSCT)

• 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 ≤2

• Participant must have adequate hepatic function

• Participant must have adequate renal function

• Participant must have adequate cardiovascular function

• Participant must have a white blood cell (WBC) count ≤20 × 10⁹/L (with stable hydroxyurea use allowed)

⁃ Participant must meet timing requirements with respect to prior therapy and surgery

⁃ 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.

Locations
United States
California
City of Hope National Medical Center
RECRUITING
Duarte
Florida
H Lee Moffitt Cancer Center and Research Institute
NOT_YET_RECRUITING
Tampa
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Ohio State University, The James Comprehensive Cancer
RECRUITING
Columbus
Pennsylvania
UPENN Perelman Center for Advanced Medicine
NOT_YET_RECRUITING
Philadelphia
Tennessee
Sarah Cannon Center for Blood Cancer at TriStar Centennia
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Auron Clinical Trials
clinicaltrials@aurontx.com
617-514-2356
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 69
Treatments
Experimental: Dose Escalation - Part A
Participants will receive escalating dosages of AUTX-703 orally in tablet form once, twice or three times weekly to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
Experimental: Dose Optimization - Part B, Dosage 1
Participants will receive AUTX-703 at the first selected dosage determined from Part A, administered orally in tablet form either once, twice or three times weekly to further evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity at this specified dose.
Experimental: Dose Optimization - Part B, Dosage 2
Participants will receive AUTX-703 at the second selected dosage determined from Part A, administered orally in tablet form either once, twice or three times weekly to further evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity at this specified dose.
Sponsors
Leads: Auron Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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