A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
City of Hope Medical Center
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.
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of AOH1996 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). II. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AOH1996. SECONDARY OBJECTIVES: I. Evaluate the anti-leukemic activity, as assessed by complete remission (CR) rate at the end of cycles 1 and 2. II. Evaluate the anti-leukemic activity, as assessed by overall response rate (\[ORR\]: CR+CR with incomplete hematologic recovery rate \[CRi\]+CR with partial hematologic recovery \[CRh\]+morphologic leukemia-free state…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Life expectancy \> 3 months * Patients with histologically confirmed AML, according to International Consensus Classification (ICC) or World Health Organization (WHO) criteria, with refractory/relapsed (R/R) disease who have failed treatment with, or are ineligible for, available therapies known to be effective for treatment of their AML * Patients with extramedullary disease may be included if they also have marro…
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
Location
- City of Hope Medical CenterDuarte, California