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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07508982
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given by IV
  • APG1252 — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
May 22, 2026
Status verified
Mar 2026
Primary completion
Dec 12, 2029
Completion
Dec 12, 2031

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Tapan Kadia, MD
Tapan Kadia, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UT MD Anderson· Houston, TX

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