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A drug, APVO436, in combination with azacitidine and venetoclax, to treat acute myeloid leukemia (AML) with marker CD123 (CD123+) that has not yet been treated

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18 and older

Phase 1

7 Locations

NCT06634394

Clinical Trial Goal


To find out:
  • The highest dose of APVO436 that's safe to give
  • If APVO436 is safe and works well to treat CD123+ AML that has not yet been treated

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have CD123+ AML that has not yet been treated
  • Do not have acute promyelocytic leukemia
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


APVO436 is a bispecific T-cell engager (BiTE) antibody that targets CD3 and CD123 on certain cells. 
Azacitidine is a drug that blocks the growth of cancer cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • APVO436 – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Azacitidine –  Given as IV infusions 1 time each day for 8 days
  • Venetoclax –  A pill that you take by mouth 1 time each day for 22 days

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 1 year.

The Food and Drug Administration (FDA) has not yet approved APVO436. 

Contacts


Caroline Taromino, 7735749572, tarominoC@apvo.com

Locations

Colorado Blood Cancer InstituteRECRUITING

Denver, Colorado
Research Coordinator, Christopher.Mckenney@SarahCannon.com

University of MiamiRECRUITING

Miami, Florida
Research Coordinator, azoso@med.miami.edu

University of KansasRECRUITING

Fairway, Kansas
Research Coordinator, ekelly4@kumc.edu

Gabrail Cancer CenterRECRUITING

Canton, Ohio
Reserach Coordinator, arich@gabrailcancercenter.com

Oncology Hematology CareRECRUITING

Cincinnati, Ohio
Research Coordinator, Douglas.Hart@usoncology.com

MD Anderson Cancer CenterRECRUITING

Houston, Texas
Research Coordinator, JWCastellano@mdanderson.org

University of Texas Southwestern Medical CenterRECRUITING

Dallas, Texas
Research Coordinator, michael.mccane@utsouthwestern.edu

ClinicalTrials.gov record


NCT06634394. First posted on 10/9/24

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