APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
NCT ID: NCT06634394
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
39 participants
INTERVENTIONAL
2024-10-01
2028-03-31
Brief Summary
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Detailed Description
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APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm APVO436 in combination with Venetoclax and Azacitidine
APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
APVO436
Infusion drug administered as a 4 hour infusion.
Venetoclax
Oral tablet given on days 1 through 22, of a 28 day cycle.
Azacitidine
Intravenous infusion given on days 1-8 of a 28 day cycle
Interventions
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APVO436
Infusion drug administered as a 4 hour infusion.
Venetoclax
Oral tablet given on days 1 through 22, of a 28 day cycle.
Azacitidine
Intravenous infusion given on days 1-8 of a 28 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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:
1. ≥75 years of age
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
3. Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
4. Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
5. Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular
6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks
Exclusion Criteria
1. A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
2. CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
3. Experimental therapies for MDS or AML
2. Patient is currently participating in another interventional research study.
3. 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.
4. Patient has acute promyelocytic leukemia.
5. Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy \>10 mg methylprednisolone daily or its equivalent
6. Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose).
7. 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.
8. Creatinine clearance \<30ml/min based on Cockcroft-Gault or MDRD formular.
9. Bilirubin of \>3xULN in the absence of Gilbert's Syndrome.
10. AST and/or ALT \>3 times the ULN.
18 Years
ALL
No
Sponsors
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Aptevo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Dirk Huebner, MD
Role: STUDY_DIRECTOR
Aptevo Therapeutics
Locations
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Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
University of Kansas
Fairway, Kansas, United States
Gabrail Cancer Center
Canton, Ohio, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APVO436-5201
Identifier Type: -
Identifier Source: org_study_id
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