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

Part of paid clinical trials in Duarte, California.

Sponsor
Auron Therapeutics, Inc.
Study ID
NCT06846606
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AUTX-703 — DRUG
    AUTX-703 administered orally

Study Details

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.

Key Dates

First listed
Feb 26, 2025
Start date
May 1, 2025
Status verified
Sep 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
69 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence of Adverse Events (AEs), Dose-Limiting Toxicities (DLTs), and Serious Adverse Events (SAEs) [ Time Frame: From the first dose through 28 days after the last dose of study drug. ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Ohio State University, The James Comprehensive CancerColumbusOhio43210-
UPENN Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
Sarah Cannon Center for Blood Cancer at TriStar CentenniaNashvilleTennessee37203-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAH Lee Moffitt Cancer Center and Research Institute· Tampa, FLRoswell Park Comprehensive Cancer Center· Buffalo, NYMemorial Sloan Kettering Cancer Center· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCOhio State University, The James Comprehensive Cancer· Columbus, OH

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