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APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML | Clinical Trials | Clareo Health

RECRUITINGPHASE1

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06634394•Aptevo Therapeutics

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•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. Patient has received treatment with the following:
•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.
+3 more criteria

Locations (7)

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

Key Dates

Start Date

October 1, 2024

Primary Completion Date

October 1, 2027

Completion Date

March 1, 2028

Last Updated

May 11, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia (AML)

Interventions

APVO436

DRUG

Venetoclax

DRUG

Azacitidine

DRUG

Contacts

Caroline Taromino

CONTACT

7735749572 tarominoC@apvo.com

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CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Inclusion Criteria

Exclusion Criteria

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