RecruitingPhase 1NCT06763341

A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia


Sponsor

City of Hope Medical Center

Enrollment

12 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase 1 trial tests safety, side effects, and best dose of AOH1996 for the treatment of patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or AML that has not responded to previous treatment (refractory). AOH1996 is in a class of medications called PCNA inhibitors. It inhibits cancer growth and induces deoxyribonucleic acid (DNA) damage. This may help keep cancer cells from growing and damage cancer cell DNA. Giving AOH1996 may be safe, tolerable and/or effective in treating patients with AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial is testing a new drug called AOH1996 in people with relapsed or treatment-resistant acute myeloid leukemia (AML) — a blood cancer that has come back or stopped responding to existing therapies. This is an early-phase trial primarily focused on safety and dosing. **You may be eligible if...** - You are 18 or older - You have AML confirmed by biopsy that has relapsed or not responded to treatment - You have either already tried available therapies or are not eligible for them - You are in reasonably good health (ECOG score ≤ 2) - You are expected to live more than 3 months - Any side effects from previous treatment have resolved to mild levels **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL), a specific AML subtype - You are in very poor health - You have AML only outside the bone marrow (extramedullary) without marrow involvement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

DRUGPCNA Inhibitor AOH1996

Given PO

DRUGVenetoclax

Given PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06763341


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