A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Primary Objective

The primary objectives of Phase 1 are: To determine the safety, tolerability, MTD, and RP2D of SNDX-5613 in patients with R/R acute leukemia in Arm A, Arm B, Arm C, and Arm D. To characterize the PK parameters of SNDX-5613 in Arm A, Arm B, Arm C, and Arm D. The primary objectives of Phase 2 are: To evaluate short- and long-term safety and tolerability of SNDX-5613. To assess the CR rate (CR+CRh) in adult patients.

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Details
Age

Child to Adult

Locations

CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Christine McMahon

Christine McMahon

Study ID

Protocol Number: 22-1050

More information available at ClinicalTrials.gov: NCT04065399

Categories

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