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Study identifier: NCT05828069 Synced from ClinicalTrials.gov · July 29, 2026
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A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

Condition: Recurrent Langerhans Cell Histiocytosis · Refractory Langerhans Cell Histiocytosis  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 2
Planned participants48
Who can joinAll sexes, 180 Days to 22 Years
Healthy volunteersNo

About this study

This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (119)

Children's Hospital of AlabamaBirmingham, Alabama, United StatesRecruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
Kaiser Permanente Downey Medical CenterDowney, California, United StatesRecruiting
Loma Linda University Medical CenterLoma Linda, California, United StatesRecruiting
Miller Children's and Women's Hospital Long BeachLong Beach, California, United StatesRecruiting
Children's Hospital Los AngelesLos Angeles, California, United StatesRecruiting
Valley Children's HospitalMadera, California, United StatesActive Not Recruiting
UCSF Benioff Children's Hospital OaklandOakland, California, United StatesRecruiting
Kaiser Permanente-OaklandOakland, California, United StatesRecruiting
Children's Hospital of Orange CountyOrange, California, United StatesRecruiting
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, California, United StatesRecruiting
UCSF Medical Center-Mission BaySan Francisco, California, United StatesRecruiting

+ 107 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05828069