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A drug, NMS-03597812, to treat acute myeloid leukemia (AML) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

7 Locations

NCT06549790

Clinical Trial Goal


To find out:
  • The highest dose of NMS-03597812 that's safe to give
  • If NMS-03597812 is safe and works well to treat AML that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have AML that has relapsed or is refractory
  • Have cancer cells with mutation/marker TP53 (TP53+). Your doctor can tell you this
  • Do not have acute promyelocytic leukemia
  • Have not had an autologous (your own cells) or allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
  • Do not have graft-versus-host-disease (GVHD)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


NMS-03597812 is a small molecule inhibitor that blocks PERK in certain cells. 

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • NMS-03597812 – A pill that you take by mouth 1 time each day

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to about 1.5 years.

The Food and Drug Administration (FDA) has not yet approved NMS-03597812.

Contacts


Alberto Ocana, +39 0331-581111, clinicaltrials@nervianoms.com

Locations

City of Hope - DuarteRECRUITING

Duarte, California

Rocky Mountain Cancer CentersRECRUITING

Aurora, Colorado

Medical Oncology Hematology ConsultantsRECRUITING

Newark, Delaware

Blood and Marrow Transplant Group of GeorgiaRECRUITING

Atlanta, Georgia

Mayo Clinic Cancer Center (MCCC) - RochesterWITHDRAWN

Rochester, Minnesota

Gabrail Cancer Research CenterRECRUITING

Canton, Ohio

The University of Texas MD Anderson Cancer CenterRECRUITING

Houston, Texas

ClinicalTrials.gov record


NCT06549790. First posted on 8/12/24

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