OncoMatch/Clinical Trials/NCT06634394
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Is NCT06634394 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including APVO436 and Venetoclax for acute myeloid leukemia (aml).
Treatment: APVO436 · Venetoclax · Azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IL3RA overexpression (CD123-positive)
Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC])
Excluded: BCR fusion
AML with BCR-ABL1 translocation
Excluded: ABL1 fusion
AML with BCR-ABL1 translocation
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: hypomethylating agent
A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
Cannot have received: venetoclax (venetoclax)
A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
Cannot have received: cytotoxic chemotherapy
A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
Cannot have received: CAR-T cell therapy
CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
Cannot have received: allogeneic hematopoietic stem cell transplant
CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
Cannot have received: experimental therapy
Experimental therapies for MDS or AML
Lab requirements
Kidney function
creatinine clearance 30-45 mL/min eligible; <30 mL/min excluded
Liver function
total bilirubin between 1.5 and 3 times the ULN; bilirubin >3xULN excluded unless Gilbert's Syndrome; AST and/or ALT >3x ULN excluded
Cardiac function
cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina); Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or MDRD formula; Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN; Bilirubin of >3xULN in the absence of Gilbert's Syndrome; AST and/or ALT >3 times the ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Colorado Blood Cancer Institute · Denver, Colorado
- University of Miami · Miami, Florida
- University of Kansas · Fairway, Kansas
- Gabrail Cancer Center · Canton, Ohio
- Oncology Hematology Care · Cincinnati, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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