NCT05360160

A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)

A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL). Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL

Detailed description

Primary Objectives: Phase Ib • To determine the safety, tolerability and recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML). Phase II • To assess the efficacy of SNDX-5613 in combination with ASTX727 and venetoclax for patients with AML. Secondary Objectives • To assess overall survival, event-free survival and duration of response. Exploratory Objectives • To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	SNDX-5613	Given by PO
DRUG	Venetoclax	Given by PO
DRUG	ASTX727	Given by PO

Timeline

• Start date: 2022-10-14
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-05-04
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study