Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors

Inclusion Criteria:

• Signed informed consent by participants ≥ 12 years of age either a Consent or anAssent Form will be provided to the patient based on their capacity, localregulations, and guidelines.

• Participants must have a histologically confirmed diagnosis of melanoma or othersolid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplificationsobtained through a tumor or liquid biopsy as assessed by genomic sequencing,polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), oranother clinically accepted molecular diagnostic method recognized by locallaboratory or regulatory agency.

• Participants must have radiographically-recurrent or radiographically-progressivedisease that is measurable using the appropriate tumor response criteria (e.g.RECIST version 1.1 or RANO).

• Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue forcorrelative studies is required

• If brain metastases are present, they must have been previously treated and bestable as assessed by radiographic imaging

Exclusion Criteria:

• Prior therapy of any RAS-, RAF-, MEK-, or ERK-directed inhibitor therapy

• Known presence of concurrent activating mutation

• Participants with current evidence or a history of central serous retinopathy (CSR),retinal vein occlusion (RVO)