Study of Radiolabeled SNDX-5613 in Adults With Acute Leukemia

Study Overview
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Brief Summary
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This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-SNDX-5613 in participants with acute leukemia.

Detailed Description
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Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from SNDX-5613 may remain on study until progressive disease (PD) or unacceptable toxicity.

Official Title
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A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia

Conditions
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Acute Leukemia

Intervention / Treatment
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* Drug: SNDX-5613


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Males and females (of non-childbearing potential) aged ≥18 years Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease. Previously received standard of care therapy Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 Adequate liver and cardiac function Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose Key Exclusion Criteria: Active diagnosis of acute promyelocytic leukemia White blood cell (WBC) count >25,000/microliters at time of enrollment. Detectable human immunodeficiency virus viral load within the previous 6 months Hepatitis B or Hepatitis C Cardiac, gastrointestinal, or graft-versus-host disease (GVHD) History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers Any commercially available or investigational antileukemic therapy other than SNDX-5613 except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting SNDX-5613 Any concurrent systemic treatment to prevent GVHD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNDX-5613<br>Participants will be administered a single dose of SNDX-5613 (containing  100 microcuries [14C]-SNDX-5613) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled SNDX-5613. SNDX-5613 may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity. | Drug: SNDX-5613<br>* Initial radiolabeled SNDX-5613 will be administered as an oral solution. Capsules will be administered thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Dose Excreted in Urine (feu) |  | Up to Day 11 | 
| Percentage of Dose Excreted in Feces (fef) |  | Up to Day 11 | 
| Amount Excreted in Urine (Aeu) |  | Up to Day 11 | 
| Amount Excreted in Feces (Aef) |  | Up to Day 11 | 
| Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t) |  | Up to Day 21 | 
| Maximum Observed Concentration (Cmax) |  | Up to Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) |  | up to approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SNDX-5613, Acute Leukemia, Refractory leukemia, Relapsed leukemia