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RecruitingPhase 1

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests five dose levels of APVO436 given with venetoclax and azacitidine. It is for adults with newly diagnosed acute myeloid leukemia (AML), a blood cancer, whose cancer cells have a marker called CD123.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have confirmed AML that has not been treated.
  • Have a test showing that the AML cells have the CD123 marker.
  • Be unable to receive intensive starting treatment because of age 75 or older, limits on daily activities, or certain heart, lung, kidney, or liver problems.
  • Be expected to live at least 12 weeks.

Who can't join

  • Have had certain prior treatments for AML or related blood disorders: drugs called hypomethylating agents, venetoclax, chemotherapy, or experimental treatment for AML or myelodysplastic syndrome (MDS). Prior CAR-T cell therapy or a stem cell transplant from a donor also rules you out.
  • Be taking part in another study that gives a treatment or other medical intervention.
  • Have a history of certain blood disorders called myeloproliferative neoplasms, or have AML with a gene change called BCR-ABL1.
  • Have acute promyelocytic leukemia, a type of AML.
  • Have an active illness where the immune system attacks the body that needs immune-suppressing treatment, such as more than 10 mg of methylprednisolone daily or an equal dose of another steroid. Taking any dose of a steroid to treat cancer also rules you out.
  • Have known active AML in the brain or spinal cord. Prior chemotherapy given into spinal fluid only to prevent this spread is allowed.
  • Have a kidney filtering rate below 30 mL/min.
  • Have bilirubin above 3 times the normal upper limit, unless you have Gilbert's syndrome, a condition that raises bilirubin. Liver enzyme levels called AST or ALT above 3 times the normal upper limit also rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (7)

CO

FL

KS

OH

TX