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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  1 to 25

Participation Criteria

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