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A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Primary Investigator
Bixby, Dale
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06226571
UM Number
2024.053
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
50337
Secondary Protocol No
HUM00253221
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Myeloid and Monocytic Leukemia
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.

Eligibility: 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).