Phase 1 Study of AOH1996 for Relapsed/Refractory Acute Myeloid Leukemia
This study is a Phase 1 clinical trial testing the safety, side effects, and best dose of a drug called AOH1996 for people with acute myeloid leukemia (AML) that has returned after treatment (relapsed) or has not responded to previous treatments (refractory). AOH1996 works by stopping cancer growth and damaging cancer cell DNA. You would receive AOH1996 by mouth, and some participants may also receive Azacitidine (given intravenously) and Venetoclax (given by mouth). The study aims to see if AOH1996 is safe and tolerable. To join, you must be at least 18 years old and have a life expectancy of more than 3 months. The study plans to enroll 12 participants.
- Study design
- This is a Phase 1 interventional study with a planned enrollment of 12 participants. It is designed to evaluate the safety and best dose of AOH1996.
- What's involved
- You would undergo blood sample collection and bone marrow aspiration. The study will monitor for side effects for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will monitor for adverse events for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06763341
A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~12 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:AzacitidineBiospecimen CollectionBone Marrow AspirationPCNA Inhibitor AOH1996Venetoclax
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicity (DLT)
Measured over During cycle 1 (Cycle length = 28 days)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Amanda Blackmon · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 marrow involvement
Patients with acute promyelocytic leukemia (APL) will not be eligible
Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
Ability to swallow pills
White blood cell (WBC) ≤ 25 x 10\^9/L prior to initiation of study therapy. Cytoreduction with hydroxyurea prior to treatment and/or during cycle 1 may be required (within 14 days prior to day 1 of protocol therapy)
Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy)
Aspartate aminotransferase (AST) =\< 3.0 x ULN (within 14 days prior to day 1 of protocol therapy)
Alanine aminotransferase (ALT) =\< 3.0 x ULN (within 14 days prior to day 1 of protocol therapy)
Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)
International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)
Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)
Corrected QT interval (QTc)F ≤ 480 ms based on Fridericia's formula
Note: To be performed within 28 days prior to day 1 of protocol therapy
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential\* to use an effective method of birth control (nonhormonal) or abstain from heterosexual activity for the course of the study through at least 2 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
Hematopoietic stem cell transplant within 100 days prior to day 1 of protocol therapy. Patients who have stopped calcineurin inhibitors (CNI) must be off CNIs for at least 2 weeks prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy with the following exception of hydroxyurea which is allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia
Strong inducers or strong inhibitors of CYP enzymes (e.g., 1A2, 2B6, 2C8, 2C9, 2C19, and 3A4), other than azole antifungals with CYP3A4 inhibition potential, or drug transporters (e.g., organic anions \[OATP1B1/1B3\], BCRP, P-gp, organic cations \[OCT1, OCT2, OCT3\], MATE1 or MATE2K), or sensitive substrates of these CYPs or drug transporters, within 4-5 half-lives or 14 days prior to the first dose of study drug, whichever is longer.
Foods/supplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment
Systemic steroid therapy \> 10 mg/day (≤ 10mg/day prednisone equivalent ok) or any other form of immunosuppressive medication within 14 days. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted
Must not have received or planning to receive live vaccine while being on study or 4 weeks before and after completion of treatment
Patients with blast phase chronic myeloid leukemia (CML)
Patients with translocation (t)(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML)
Active central nervous system (CNS) disease
Active graft versus (vs) host disease (GVHD)
Unstable cardiac disease as defined by one of the following:
Cardiac events such as myocardial infarction (MI) within the past 6 months
Uncontrolled atrial fibrillation or hypertension
No measurable disease in the bone marrow
Gastrointestinal disorder that interferes with oral drug absorption such as malabsorption syndrome
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Uncontrolled active infection
Clinically significant uncontrolled illness
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Incidence of dose limiting toxicity (DLT)During cycle 1 (Cycle length = 28 days)
Will evaluate for DLTs in patients that receive at least 75% of the planned dose(s) of AOH1996 per dose level assignment. In-evaluable subjects will be replaced. Will grade toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
- Incidence of adverse eventsUp to 2 years
Will evaluate toxicity in patients that receive any AOH1996. Will grade toxicity according to the NCI CTCAE v5.0. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.