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

NCT06226571 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: SNDX-5613-07082024-514531-18-00
• Study Type: interventional
• Target: 76
• Locations: 6 countries
• Sites: 46

Brief 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.

Conditions

Acute Myeloid Leukemias

Keywords

SNDX-5613; Lysine-specific Methyltransferase 2A; KMT2A/MLL; Nucleophosmin 1; NPM1; Nucleoporin 98; NUP98; AML

Outcome Measures

Primary Outcomes (2)

• Dose Escalation: Number of Participants with Dose-limiting Toxicities

  Up to Day 42

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Day 1 through 30 days after final dose (up to approximately 3 years)

Secondary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of SNDX-5613 and Relevant Metabolites

  Predose through Day 15

• Area Under the Plasma Concentration Versus Time Curve From Time 0 to t (AUC0-t) of SNDX-5613 and Relevant Metabolites

  Predose through Day 15

Study Arms (1)

SNDX-5613

EXPERIMENTAL

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.

Drug: SNDX-5613; Drug: Chemotherapy Regimen; Drug: HiDAC

Interventions

SNDX-5613 DRUG

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

SNDX-5613

Chemotherapy Regimen DRUG

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

SNDX-5613

HiDAC DRUG

Consolidation: Participants will receive HiDAC IV.

SNDX-5613

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Syndax Pharmaceuticals: lead

Study Sites (46)

UCLA Medical Hematology

Burbank, California, 91505, United States

RECRUITING

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

AdventHealth Blood & Marrow Transplant Center

Orlando, Florida, 32804, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

University of Louisville Health Brown Cancer Center

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, 40207, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Institution name: Northwell Health-Brany

Lake Success, New York, 11042, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health and Science University- Center for Hematologic Malignancies

Portland, Oregon, 97239, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MUSC Hollings Cancer Center (HCC)

Charleston, South Carolina, 29425, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

LDS Hospital - Intermountain Healthcare

Salt Lake City, Utah, 84143, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Northern Hospital, Victoria

Epping, Victoria, 3076, Australia

RECRUITING

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, SA 5000, Australia

RECRUITING

The Alfred Hospital, Victoria

Melbourne, 3004, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, 6009, Australia

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Gordon and Leslie Diamond Health Care Center

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

University Medical Center Utrecht

Utrecht, 3584, Netherlands

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

RECRUITING

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

RECRUITING

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario De Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

RECRUITING

Universitat de Valencia

Valencia, 46026, Spain

RECRUITING

Hammersmith Hospital

London, London, City of, W12 0HS, United Kingdom

RECRUITING

The Royal Marsden NHS

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Syndax Pharmaceuticals

CONTACT

781-419-1400; clinicaltrials@syndax.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 26, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9); GB (2); CA (3); NL (1); AU (5); US (26)