Acute Myeloid Leukemia (AML)Phase 1NCT06634394
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
A Phase 1 study testing APVO436, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by Aptevo Therapeutics at 7 sites in United States.
Trial summary
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- APVO436, Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2024to Mar 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
- 1. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated.
- 3. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]). Confirmation at diagnosis is acceptable.
- 4. Patient must be considered ineligible for induction therapy defined by at least one of the following:
- ≥75 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
- Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
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- Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
- Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular
- Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks
Who cannot join
- Patient has received treatment with the following:
- A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
- CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
- Experimental therapies for MDS or AML
- Patient is currently participating in another interventional research study.
- Patient has history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
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- Patient has acute promyelocytic leukemia.
- Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy >10 mg methylprednisolone daily or its equivalent
- Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose).
- Patient has known active CNS involvement with AML. Patients who received intrathecal chemotherapy for prophylaxis of AML in the CNS prior to enrollment may enroll in this study.
- Creatinine clearance <30ml/min based on Cockcroft-Gault or MDRD formular.
- Bilirubin of >3xULN in the absence of Gilbert's Syndrome.
- AST and/or ALT >3 times the ULN.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
Reserach Coordinator, arich@gabrailcancercenter.com
- Recruiting
Oncology Hematology Care
Cincinnati, Ohio, 45226
Research Coordinator, Douglas.Hart@usoncology.com
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Research Coordinator, michael.mccane@utsouthwestern.edu
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Research Coordinator, Christopher.Mckenney@SarahCannon.com
- Recruiting
University of Kansas
Fairway, Kansas, 66205
Research Coordinator, ekelly4@kumc.edu
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Research Coordinator, JWCastellano@mdanderson.org
- Recruiting
University of Miami
Miami, Florida, 33124
Research Coordinator, azoso@med.miami.edu
About this study
Official title: A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
Read the detailed description
Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. In Cycle 1 (C1) only, to reduce the risk of CRS, each cohort will receive 4 priming doses of APVO436 respectively. APVO436 will be given in combination with venetoclax and azacitidine. For C1D15 and all doses in each subsequent cycle, cohorts will receive APVO436 at the determined cohort dose level.
APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- APVO436, Venetoclax, Azacitidine
- Keywords
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APVO436Drug
Infusion drug administered as a 4 hour infusion.
VenetoclaxDrug
Also called venclexta
Oral tablet given on days 1 through 22, of a 28 day cycle.
AzacitidineDrug
Also called vidaza
Intravenous infusion given on days 1-8 of a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm APVO436 in combination with Venetoclax and Azacitidine | Experimental | APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML. Receives: Drug: APVO436; Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax/azacitidine in patients with newly diagnosed AML
Incidence and severity of treatment emergent adverse events (TEAEs), including ≥Grade 3 adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs: ≥Grade 2 infusion related reaction (IRR), ≥Grade 2 cardiac toxicity, and ≥Grade 2 neurotoxicity as complication of cytokine release syndrome [CRS]).
Measured: Through the end study completion average of 1 year.
Secondary outcomes (1)
Determine the efficacy of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML
Complete remission (CR) rate
Measured: Through the end study completion 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.
- First posted9 Oct 2024
- Study start1 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptevo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirk Huebner, MD, Study director, Aptevo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634394
- Sponsor's protocol ID
- APVO436-5201
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT06634394
- Acronym / sponsor ID
- APVO436-5201
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Aptevo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
Detailed description
Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. In Cycle 1 (C1) only, to reduce the risk of CRS, each cohort will receive 4 priming doses of APVO436 respectively. APVO436 will be given in combination with venetoclax and azacitidine. For C1D15 and all doses in each subsequent cycle, cohorts will receive APVO436 at the determined cohort dose level.
APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm APVO436 in combination with Venetoclax and Azacitidine | Experimental | Drug: APVO436, Drug: Venetoclax, Drug: AzacitidineAPVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated.
- 3. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]). Confirmation at diagnosis is acceptable.
- 4. Patient must be considered ineligible for induction therapy defined by at least one of the following:
Key exclusion criteria (13 listed)
- Patient has received treatment with the following:
- Patient is currently participating in another interventional research study.
- Patient has history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
- Patient has acute promyelocytic leukemia.
- Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy >10 mg methylprednisolone daily or its equivalent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APVO436Infusion drug administered as a 4 hour infusion. | Drug | Treatment Arm APVO436 in combination with Venetoclax and Azacitidine |
| VenetoclaxAlso: venclextaOral tablet given on days 1 through 22, of a 28 day cycle. | Drug | Treatment Arm APVO436 in combination with Venetoclax and Azacitidine |
| AzacitidineAlso: vidazaIntravenous infusion given on days 1-8 of a 28 day cycle | Drug | Treatment Arm APVO436 in combination with Venetoclax and Azacitidine |
Primary outcome
To assess the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax/azacitidine in patients with newly diagnosed AML
Time frame: Through the end study completion average of 1 year.
Incidence and severity of treatment emergent adverse events (TEAEs), including ≥Grade 3 adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs: ≥Grade 2 infusion related reaction (IRR), ≥Grade 2 cardiac toxicity, and ≥Grade 2 neurotoxicity as complication of cytokine release syndrome [CRS]).
1 secondary outcome
Determine the efficacy of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML
Time frame: Through the end study completion average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dirk Huebner, MD study director
Aptevo Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APVO436, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by Aptevo Therapeutics at 7 sites 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 9 inclusion and 13 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 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Contact Caroline Taromino (7735749572, tarominoC@apvo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax/azacitidine in patients with newly diagnosed AML (time frame: Through the end study completion average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025.