DAY101 Monotherapy or in Combination With Other Therapies for Patients With Solid Tumors

Inclusion Criteria:

Signed informed consent by patients ≥ 18 years of age and, assent for patients ≥ 12 up to < 18 years of age
Patients must have a histologically confirmed diagnosis of tumor with concurrent MAPK pathway alteration as assessed by sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency
Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1)
Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging

Exclusion Criteria:

Known presence of concurrent activating mutation
Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)

Substudy A-specific exclusion criterion:

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

Substudy B-specific exclusion criterion:

Prior receipt of any Type-II pan-RAF inhibitor therapy (e.g., LXH254/naporafenib, BGB- 283, BGB-3245, belvarafenib)