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

Stopped early · Phase 1

Conditions studied: Malignant Melanoma, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Primary, Brain Neoplasms, Malignant Neoplasms

In brief

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.

Key facts

Study ID

NCT04543188

Run by

Pfizer

People needed

65

Starts

2021-01-08

Expected to finish

2024-03-20

Last updated by the study team

2025-10-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Richard M Schulze Family Foundation Outpatient Center at McKinley Campus — Tampa, Florida, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Johns Hopkins University / Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Ophthalmic Consultants of Boston Inc (OCB) — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Imaging: Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Imaging: Brigham and Women's Radiology, Coolidge Corner Imaging — Brookline, Massachusetts, United States
• Imaging: Brigham and Women's Ambulatory Care — Chestnut Hill, Massachusetts, United States
• Imaging: Brigham and Women's Mass General Healthcare Center — Foxborough, Massachusetts, United States
• Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, United States
• Siteman Cancer Center - St Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Siteman Cancer Center - North County — Florissant, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Siteman Cancer Center - South County — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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