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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Day One Biopharmaceuticals, Inc.

Criteria

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 non-hematologic tumor with an activating BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification.

• 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:

• Prior therapy with BRAF-, MEK-, or MAPK-directed inhibitor therapy, except for tumor types and indications where such therapy has been approved by the FDA or applicable regulatory authorities

• Known presence of concurrent activating mutation

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