TerminatedPhase 1NCT04543188

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

StatusTerminated
PhasePhase 1
U.S. locations45
SponsorPfizer
01
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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Explore related studies

How this study is categorized

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

Biomarkers
03
Public criteria

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.

04
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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