A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement.
Checked against the public recordLast updated Oct 23, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: PF-07284890; Drug: Binimetinib; Drug: Midazolam
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 Exclusion Criteria: * Brain metastasis/primary brain tumor requiring immediate local intervention * History of or current leptomeningeal metastases * Any other active malignancy within 2 years prior to enrollment * Radiation therapy to visceral metastases within 14 days prior to study treatment. WBRT within 28 days prior to study treatment. * Systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to start of study treatment; Antibody based agents within 4 weeks prior to start of study treatment. * History or current evidence of RVO or current risk factors for RVO; History of retinal degenerative disease
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Orlando Health Cancer InstituteOrlando, Florida
- Moffitt Cancer CenterTampa, Florida
- Richard M Schulze Family Foundation Outpatient Center at McKinley CampusTampa, Florida
- Northwestern Medical GroupChicago, Illinois
- Northwestern Memorial HospitalChicago, Illinois
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Johns Hopkins University / Johns Hopkins HospitalBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Ophthalmic Consultants of Boston Inc (OCB)Boston, Massachusetts
- Brigham & Women's HospitalBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2025. Always confirm current availability with the study team.