A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT06226571
Trial Phases:	Phase I	Protocol IDs:	SNDX-5613-0708 (primary) NCI-2024-01922
Eligibility:	18 - 75 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Syndax Pharmaceuticals
NCI Full Details:	http://clinicaltrials.gov/show/NCT06226571

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants
with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1,
or NUP98 genes.

Objectives

The Dose Escalation portion of this study will identify the maximum tolerated dose, or if
different, the recommended Phase 2 dose of SNDX-5613 to be used in combination with
intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in
participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98
genes.

In the Dose Expansion portion of the study, safety and preliminary efficacy of SNDX-5613
may be explored in expansion cohorts at tolerated dose levels.

In both Dose Escalation and Dose Expansion, the treatment period will consist of an
induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include
hematopoietic stem cell transplant for participants who are transplant eligible and have
an available donor), and a maintenance monotherapy phase with SNDX-5613. The cycle
duration will be 28 days.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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