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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-07284890 and Binimetinib

Plus 1 other study approaches.

Who it may be forBRAF

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?45 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers

BRAF→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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