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

Launched by APTEVO THERAPEUTICS · Oct 8, 2024

Keywords

ClinConnect Summary

The APVO436 clinical trial is a research study aimed at finding the best dose of a new treatment called APVO436, which is being tested alongside two other medications, venetoclax and azacitidine, for adults who have just been diagnosed with a type of blood cancer known as Acute Myeloid Leukemia (AML). This study is specifically for patients whose AML cells have a marker called CD123, and it is designed for those who cannot receive standard initial treatments due to age or health issues.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of AML, and should not have received any prior treatment for this condition. Additionally, they should have certain health limitations, such as being 75 years or older, having specific heart or lung issues, or having reduced kidney function. During the trial, participants will receive the study treatment and will be closely monitored for its effects, helping researchers understand how well it works and what side effects it may cause. It's important to note that this trial is not yet recruiting participants, so interested individuals should keep an eye out for when enrollment begins.

Gender

ALL

Eligibility criteria

• 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.
• • 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.