OncoMatch/Clinical Trials/NCT06634394
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Is NCT06634394 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06634394 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require IL3RA?
Yes, IL3RA overexpression is a required biomarker for enrollment.
Are patients with BCR alterations eligible?
No. BCR fusion is an exclusion criterion.
Are patients with ABL1 alterations eligible?
No. ABL1 fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages