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Acute Myeloid LeukemiaPhase 1NCT06357182

Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study testing Azacitidine, Biospecimen Collection and Bone Marrow Biopsy in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome/Acute Myeloid Leukemia, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Azacitidine, Biospecimen Collection and Bone Marrow Biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
22 Aug 2024to 29 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients at least 18 years of age will be considered for inclusion without bias against gender identity, race, or ethnicity
  • Ability to comprehend the investigational nature of the study and provide written informed consent
  • Patients with previously untreated, morphologically documented AML based on World Health Organization (WHO) 2008 definitions who are ineligible for standard of care (SOC) intensive chemotherapy (IC) induction OR documented unwillingness to undergo IC induction. Ineligible for IC is defined as:
  • Documented intermediate- or adverse-risk AML based on European Leukemia Network (ELN) 2022 criteria
  • Note: Cases of AML (MDS) overlap with 10-19% bone marrow (BM) or peripheral blood (PB) blasts will be considered
  • Note: Cases of acute promyelocytic leukemia (PML) and AML with BCR::ABL1 fusions will be excluded
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  • Eastern Cooperative Oncology Group (ECOG) performance ≤ 2 (Patients aged ≥ 75 years, at the time of consent)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Patients aged ≥ 75 years, at the time of consent)
  • High total bilirubin values may require indirect and direct bilirubin testing. Individuals with known Gilbert's syndrome may be considered for enrollment despite high indirect (and total) bilirubin
  • Creatinine clearance (CrCl) of ≥ 60 mL/min (estimated using the Cockcroft Gault formula or measured by 24 hours urine collection. If altered, CrCl is determined to be related to concomitant medication that alters renal function
  • Patients aged ≥ 18 to 74 years (ECOG performance status [PS] ≤ 3 is accepted) at consent must meet ≥ 1 of the following criteria defining a co morbidity:
  • ECOG PS of 2 or 3 (Note: Patients ≥ 18 to 74 years of age with PS of 0-1 must meet criteria of one of the following comorbidities.)
  • Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina
  • Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%
  • CrCl ≥ 30 mL/min to < 45 ml/min
  • Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN;
  • High total bilirubin values may require indirect and direct bilirubin testing. Individuals with known Gilbert's syndrome may be considered for enrollment despite high indirect (and total) bilirubin
  • Other comorbidities that the physician judges to be incompatible with intensive chemotherapy (IC). In these cases, the comorbidity must be reviewed and approved by the principal investigator (PI) before study enrollment
  • Ability to swallow oral medications
  • No ongoing anticoagulation or antiplatelet therapy within 14 days of start of treatment with IADA
  • No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • No history of stroke or intracranial hemorrhage within 180 days of start of IADA
  • No major bleeding event, as defined by the International Society of Thrombosis and Hemostasis (ISTH), within 12 weeks of start of IADA
  • Uncorrected international normalized ratio (INR) or activated partial thromboplastin time (aPTT) of < 1.5 x ULN.
  • If INR or aPTT > 1.5 x ULN has been corrected (prior to enrollment), then history of disseminated intravascular coagulation (DIC) must be absent
  • White blood cell (WBC) < 20 x 10^9/L prior to study start. Cytoreduction prior to study treatment is allowed with
  • Hydroxyurea for up to 14 days and until 24 hours prior to start of IADA; or
  • Leukapheresis for up to 14 days prior to start of IADA
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x institutional ULN
  • Lower hepatic function may be considered if liver enzyme abnormalities are determined by the treating MD and principal investigator (PI) to be due to leukemic infiltration
  • Willing and able to
  • Adhere to study schedule of activities and life style restrictions while on treatment;
  • Provide bone marrow (BM) aspirate and core biopsy samples; and
  • Accept supportive and prophylactic care for hematologic toxicities, infection, and immediate sequelae, including transfusions
  • Negative pregnancy test within 72 hours of start of IADA for persons of childbearing potential (PCBP)
  • Willingness to comply with study requirements for contraception, as follows: PCBP and sperm-producing participants who are sexually active with a PCBP must use study approved contraception from start of investigational product (first dose of IADA) until 6 months after the last dose of IADA. Pregnancy is exclusionary because the agents used in this study have the potential for teratogenic or abortifacient effects

Who cannot join

  • Prior allergic response to iadademstat (IADA), venetoclax, azacitidine, or any excipients in the formulations
  • Body weight < 50 kg
  • Investigational therapy within 5 half-lives or, if unknown, within 28 days prior to start of IADA
  • Treatment for AML within 14 days prior to start of IADA. Cytoreduction for patients with proliferative disease must meet the criteria listed in inclusion criteria
  • Radiotherapy less than 14 days prior to start of IADA
  • Recent and significant medical interventions, such as major surgery within 28 days prior to the start of IADA, or stem cell transplant within 100 days prior to the start of IADA. Patients with active treatment for graft-versus-host disease (GVHD) are excluded
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  • Another active malignancy within 5 years prior to the start of IADA, or at the investigator's discretion
  • Treatments targeting or inhibiting LSD1/KDM1A or BCL 2 within 12 months prior to the start of IADA
  • Documented dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally
  • Treatment with monoamine oxidase inhibitors (e.g., tranylcypromine), if treatment is not finalized at least 3 weeks prior to the start of IADA
  • Active central nervous system involvement with AML
  • Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to start of IADA and must be amenable to alternate treatment if current treatment will interact with investigational regimen
  • Active hepatic disorder or documented positive hepatitis B or C virus (HBV/HCV, respectively) status, except in cases of undetectable HBV/HCV viral load for at least 3 months prior to the start of IADA. (Hepatitis B or C testing is not required for eligibility assessment.)
  • Individuals serology positive for human immunodeficiency virus (HIV) and under active treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents). Otherwise, enrollment may be considered in cases of HIV that is controlled with another treatment type or in cases that that acceptable modification of the patient's HIV treatment exists
  • Use a P-gp inhibitor within 21 days or 3 half-lives whichever is longer prior to treatment with venetoclax
  • Use of strong or moderate CYP3A4 inducers or inhibitors within 2 days or 3 half lives whichever is longer, prior to start of treatment with venetoclax
  • Unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided throughout the study and until at least 60 days after last dose of IADA
  • Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of anti-hypertensive agents to control hypertension before C1D1 is allowed
  • Patients with poorly controlled diabetes. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) ≥ 8%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met
  • Patients with mean of triplicate corrected QT interval (Fridericia's correction formula [QTcF]) > 450 ms at Screening based on central reading
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, unstable cardiac or pulmonary function or acute insufficiency (e.g., symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), or psychiatric illness or social situation that could limit compliance with study requirements, at the discretion of the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Curtis A. Lachowiez, 503-494-6157, lachowie@ohsu.edu

    Curtis A. Lachowiez

    Recruiting

Other trials in United States

About this study

Official title: A Phase Ib Investigation of the LSD1 Inhibitor Iadademstat (ORY-1001) in Combination With Azacitidine and Venetoclax in Newly Diagnosed AML

This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of iadademstat (IADA) when administered as part of the investigational combination (i.e., iadademstat + azacitidine + venetoclax [IADA+AZA+VEN]).

SECONDARY OBJECTIVES:

  1. Assess the preliminary efficacy of the investigational regimen based on disease remission.

II. Assess the preliminary efficacy of the investigational regimen based on clinical response.

III. Assess the safety of the investigational regimen.

EXPLORATORY OBJECTIVES:

  1. Assess survival in the absence of treatment failure, hematologic relapse, or progressive disease.

II. Assess overall survival.

III. Assess duration of response, based on morphological assessments.

IV. Identify mechanisms of transcriptional reprogramming and cell death.

  1. Identify predictive biomarkers of response to LSD1 inhibition.

VI. Assess participant quality of life using Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE).

OUTLINE: This is a dose-escalation study of iadademstat in combination with azacitidine and venetoclax.

Patients receive iadademstat orally (PO) once daily (QD) on days 1-5, 8-12, and 15-19. Patients also receive venetoclax PO QD on days 1-21 or 1-28 and azacitidine subcutaneously (SC) or intravenously (IV) QD on days 1-7 or 1-5 and 8-9. Patients with complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete blood count recovery, (CRi), or morphologic leukemia-free state (MLFS) after cycle 1 continue to receive IADA PO QD on days 1-5, 8-12, and 15-19, azacitidine SC or IV QD on days 1-7 or 1-5 and 8-9, and venetoclax PO QD on days 1-7, 1-14, 1-21 or 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and as clinically indicated on study. Patients undergo bone marrow biopsy throughout the trial. Additionally, patients undergo blood sample collection during screening and on the trial.

Being tested
Azacitidine, Biospecimen Collection, Bone Marrow Biopsy, Echocardiography Test, Iadademstat
Medical subject headings
Leukemia, Myeloid, Acute, GATA2 Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Also called 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine

    Given SC

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • IadademstatDrug

    Also called ORY 1001, ORY-1001, RG 6016, RG6016

    Given PO

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Questionnaire AdministrationOther

    Ancillary study

  • VenetoclaxDrug

    Also called ABT 199, ABT-0199, ABT-199, ABT199

    Given PO

Study groups in NCT06357182
Study groupRoleWhat they receive
Treatment Dose Level -1 (iadademstat, azacitidine, venetoclax)ExperimentalIadademstat (75 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-14), Azacitidine (75 mg/m2, day 1-7) Patients receive iadademstat PO QD on days 1-5 of cycle 0 and then days 1-5, 8-12, and 15-19. Patients also receive venetoclax PO QD days 1-21 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or MLFS after cycle 1 continue to receive IADA PO QD on days 1-5, 8-12, and 15-19, azacitidine SC QD days 1-7 and venetoclax PO QD days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening as clinically indicated on study. Patients under bone marrow biopsy throughout the trial. Additionally, patients undergo blood sample collection during screening and on the trial.
Receives: Drug: Azacitidine; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Echocardiography Test; Drug: Iadademstat; Procedure: Multigated Acquisition Scan; Other: Questionnaire Administration; Drug: Venetoclax
Treatment Dose Level -2 (iadademstat, azacitidine, venetoclax)ExperimentalIadademstat (75 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-7), Azacitidine (50 mg/m2, day 1-7). Patients receive iadademstat PO QD on days 1-5 of cycle 0 and then days 1-5, 8-12, and 15-19. Patients also receive venetoclax PO QD days 1-21 azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or MLFS after cycle 1 continue to receive IADA PO QD on days 1-5, 8-12, and 15-19, azacitidine SC QD days 1-7 and venetoclax PO QD days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening as clinically indicated on study. Patients under bone marrow biopsy throughout the trial. Additionally, patients undergo blood sample collection during screening and on the trial.
Receives: Drug: Azacitidine; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Echocardiography Test; Drug: Iadademstat; Procedure: Multigated Acquisition Scan; Other: Questionnaire Administration; Drug: Venetoclax
Treatment Dose Level 1 (iadademstat, azacitidine, venetoclax)ExperimentalIadademstat (100 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-21), Azacitidine (75 mg/m2, day 1-7) Patients receive iadademstat PO QD on days 1-5 of cycle 0 and then days 1-5, 8-12, and 15-19. Patients also receive venetoclax PO QD days 1-21 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or MLFS after cycle 1 continue to receive IADA PO QD on days 1-5, 8-12, and 15-19, azacitidine SC QD days 1-7 and venetoclax PO QD days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening as clinically indicated on study. Patients under bone marrow biopsy throughout the trial. Additionally, patients undergo blood sample collection during screening and on the trial.
Receives: Drug: Azacitidine; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Echocardiography Test; Drug: Iadademstat; Procedure: Multigated Acquisition Scan; Other: Questionnaire Administration; Drug: Venetoclax
Treatment Dose Level 2 (iadademstat, azacitidine, venetoclax)ExperimentalIadademstat (150 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-21), Azacitidine (75 mg/m2, day 1-7) Patients receive iadademstat PO QD on days 1-5 of cycle 0 and then days 1-5, 8-12, and 15-19. Patients also receive venetoclax PO QD days 1-21 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or MLFS after cycle 1 continue to receive IADA PO QD on days 1-5, 8-12, and 15-19, azacitidine SC QD days 1-7 and venetoclax PO QD days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening as clinically indicated on study. Patients under bone marrow biopsy throughout the trial. Additionally, patients undergo blood sample collection during screening and on the trial.
Receives: Drug: Azacitidine; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Echocardiography Test; Drug: Iadademstat; Procedure: Multigated Acquisition Scan; Other: Questionnaire Administration; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels

    Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0).

    Measured: Start of IADA (cycle 1 of combination therapy) to end of cycle 1 (each cycle is 28 days)

Secondary outcomes (3)

  1. Percentage of efficacy-evaluable participants achieving composite complete remission (cCR)

    Will be defined as achievement of complete remission (CR) or CR with partial hematologic recovery (CRh) or CR with incomplete blood count recovery (CRi) while on iadademstat+ azacitidine + venetoclax (IADA+AZA+VEN). Will be estimated for the efficacy-evaluable population with point estimates and exact binomial confidence intervals (CIs) as summary statistics. CRc rate will also be modeled with univariable logistic regressions to determine if any baseline patient or disease feature is correlated with clinical response as defined by these efficacy metrics.

    Measured: Start of IADA (cycle 1 of combination therapy) to end of investigational study treatment, average of 1 year

  2. Percentage of efficacy-evaluable participants achieving an overall response (ORR)

    Will be defined as the proportion of efficacy-evaluable participants who attain a PR or better (i.e., CR, CRh, CRi, morphologic leukemia-free state, or partial remission [PR]) while on IADA+AZA+VEN. Will be estimated for the efficacy-evaluable population with point estimates and exact binomial CIs as summary statistics. ORR will also be modeled with univariable logistic regressions to determine if any baseline patient or disease feature is correlated with clinical response as defined by these efficacy metrics.

    Measured: Start of IADA (cycle 1 of combination therapy) to end of investigational study treatment, average of 1 year

  3. Incidence of treatment-emergent grade ≥ 3 adverse events (AEs)

    Will be reported with descriptive statistics, at the overall patient level and by grade, attribution (i.e., a separate table for treatment-related AEs), and seriousness (i.e., separate tables for serious adverse events).

    Measured: Start of IADA (cycle 1 of combination therapy) to end of investigational study treatment, average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start22 Aug 2024
  3. Primary completion8 Mar 2027 (estimated)
  4. Study completion29 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The treatment plan starts with a 7 day monotherapy lead-in (Cycle 0 \[C0\]) and then proceeds to combination therapy in 28 day cycles. Disease will be assessed pre-treatment (Screening/Baseline), at the end of monotherapy, in C1 (and C2, if response is not observed in C1), and at the end of alternating cycles, thereafter. A disease assessment will also be conducted within 30 days of the last dose of IADA. Participants that do not achieve response after up to 2 cycles of the triplet regimen will be taken off treatment.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357182
Sponsor's protocol ID
STUDY00026136
Other IDs
NCI-2024-01262, STUDY00026136
Status last verified
Jun 2026
First submitted
29 Feb 2024
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azacitidine, Biospecimen Collection and Bone Marrow Biopsy in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome/Acute Myeloid Leukemia, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels (time frame: Start of IADA (cycle 1 of combination therapy) to end of cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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