Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML

NCT07508982 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-1579NCI-2026-02429
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.

Conditions

AML

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (3)

Cohort A: Part II Cohort A Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AML

EXPERIMENTAL

Treatment will be administered on an inpatient or outpatient basis. All induction and consolidation intravenous infusions of APG-1252 will be administered at MD Anderson Cancer Center (MDACC).

Drug: Azacitidine; Drug: APG1252

Cohort B: Part II Cohort B Treatment with Azacitidine (IV or SQ)+APG1252 (IV) Q4W untreated AML

EXPERIMENTAL

Treatment will be administered on an inpatient or outpatient basis. All induction and consolidation intravenous infusions of APG-1252 will be administered at MD Anderson Cancer Center (MDACC).

Drug: Azacitidine; Drug: APG1252

Lead-In: Part I Lead-In Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AML

EXPERIMENTAL

Treatment will be administered on an inpatient or outpatient basis. All induction and consolidation intravenous infusions of APG-1252 will be administered at MD Anderson Cancer Center (MDACC).

Drug: Azacitidine; Drug: APG1252

Interventions

Azacitidine DRUG

Given by IV

Also known as: Vidaza, Onureg

Cohort A: Part II Cohort A Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AML; Cohort B: Part II Cohort B Treatment with Azacitidine (IV or SQ)+APG1252 (IV) Q4W untreated AML; Lead-In: Part I Lead-In Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AML

APG1252 DRUG

Given by IV

Also known as: Pelcitoclax

Cohort A: Part II Cohort A Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AML; Cohort B: Part II Cohort B Treatment with Azacitidine (IV or SQ)+APG1252 (IV) Q4W untreated AML; Lead-In: Part I Lead-In Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AML

Eligibility Criteria

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

You may qualify if:

• Part I, Lead-in phase and Part II, Cohort A:
• Patients with relapsed and/or refractory AML Patients with high-risk MDS/AML who have had prior therapy will also be included
• Part II, Cohort B
• Patients with untreated, newly diagnosed AML of the following subtypes:
• AML-M6 or AML-M7 by FAB or having erythroid or megakaryocytic differentiation by WHO 2022 classification
• High-risk MDS/AML with erythroid differentiation and no prior therapy
• AML with MECOM rearrangement, including, but not limited to t(3;3), inv(3q), confirmed by conventional karyotype or FISH for MECOM rearrangement.
• Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of APG1252 in combination with AZA in patients \<18 years of age, children are not included in this study at this time.
• Adequate organ function as defined below:
• Liver function (bilirubin \< 2mg/dL, AST and ALT \<3 x ULN - or ≤5 x ULN if related to leukemic involvement) Kidney function (estimated creatinine clearance \> 50 mL/min). Known cardiac ejection fraction of \> or = 45% within the past 3 months
• ECOG performance status of ≤ 2.
• A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
• Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• History of hysterectomy or bilateral salpingo-oophorectomy.

You may not qualify if:

• Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• History of hysterectomy or bilateral salpingo-oophorectomy.
• Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure.
• Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient with documented hypersensitivity to any of the components of the therapy program.
• Patients with known active, uncontrolled CNS leukemia will not be eligible.
• Patients with prior treatment with a BCL-XL inhibitor will not be eligible.
• Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
• Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies) unless HIV RNA is undetectable by PCR.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. Hepatitis B virus DNA and HCV RNA must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Related Links

• UT MD Anderson Website

MeSH Terms

Interventions

Azacitidine; pelcitoclax

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Tapan Kadia, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tapan Kadia, MD

CONTACT

(713) 563-3534; tkadia@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): December 12, 2029
• Study Completion (Estimated): December 12, 2031
• Last Updated: June 2, 2026

Record last verified: 2026-03

Locations

US (1)