A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

Inclusion Criteria

• •Age ≥16 years at the time of consent
• •Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
• •Documented evidence of a BRAF V600 mutation in tumor tissue or blood
• •Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
• •Presence or absence of brain involvement unless specified below
• •Dose Expansion (Part B)
• •* Cohort 1, 2, 3, 4: melanoma with at least 1 parenchymal brain lesion
• •* Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
• •* Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
• •* Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
• •* Optional Cohort 6 (DDI Sub-study) and 7 (Food-Effect): if brain involvement present, must be asymptomatic
• •Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below
• •Dose Expansion (Part B)
• •* Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
• •* Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
• •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1