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A Study of SNDX-5613 in Combi...

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

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemias

Study Design

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Allocation Method

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SNDX-5613

Dose Escalation:

* Induction: Sequential cohorts of escalating dose levels of SNDX-5613 with chemotherapy regimen.
* Consolidation: Cohorts will receive high-dose cytarabine (HiDAC) chemotherapy followed by SNDX-5613.
* Maintenance Monotherapy: Cohorts will receive SNDX-5613.

Dose Expansion:

* Induction: SNDX-5613 at tolerated dose level with chemotherapy regimen.
* Consolidation: Cohorts will receive SNDX-5613 with chemotherapy regimen and HiDAC.
* Maintenance Monotherapy: Cohorts will receive SNDX-5613.

Group Type EXPERIMENTAL

SNDX-5613

Intervention Type DRUG

Participants will receive SNDX-5613 orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation.

Chemotherapy Regimen

Intervention Type DRUG

Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin.

HiDAC

Intervention Type DRUG

Consolidation: Participants will receive HiDAC IV.

Interventions

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SNDX-5613

Participants will receive SNDX-5613 orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation.

Intervention Type DRUG

Chemotherapy Regimen

Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin.

Intervention Type DRUG

HiDAC

Consolidation: Participants will receive HiDAC IV.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
* Previously untreated AML and eligible to receive intensive chemotherapy.
* KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
* Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old .
* Adequate liver, kidney, and cardiac function.

Exclusion Criteria

* Diagnosis of acute promyelocytic leukemia.
* Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
* Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
* Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
* Cirrhosis with a Child-Pugh score of B or C.
* Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
* Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
* Documented active, uncontrolled infection.
* Uncontrolled disseminated intravascular coagulation.
* Lactating/breast feeding or pregnant.
* Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
* Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers