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A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Advanced Solid Tumor | Low-grade Glioma

FIREFLY-1 is an ongoing, Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    1 to 25

Critères de participation

Inclusion Criteria:

* Age 6 months to 25 years with:

1. Arms 1 \& 2: a relapsed or progressive LGG with documented known activating BRAF alteration
2. Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion
* Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration
* Must have received at least one line of systemic therapy and have evidence of radiographic progression
* Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria

Exclusion Criteria:

* Patient's tumor has additional previously-known activating molecular alterations
* Patient has symptoms of clinical progression in the absence of radiographic progression
* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
* Other inclusion/exclusion criteria as stipulated by protocol may apply

Lieu de l'étude

Centre Mère-Enfant Soleil du CHU
Centre Mère-Enfant Soleil du CHU
Québec, Quebec
Canada

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Centre Hospitalier Universitaire Ste-Justine
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec
Canada

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Montreal Children's Hospital
Montreal Children's Hospital
Montreal, Quebec
Canada

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Étude parrainée par
Day One Biopharmaceuticals, Inc.
Participants recherchés
Plus d'informations
ID de l'étude: NCT04775485