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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    225
  • sponsor
    Pfizer
Updated on 4 June 2021
BRAF
solid tumor
metastatic solid tumor
braf inhibitor
immunostimulants
braf v600 mutation
immunologic adjuvant

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.

Details
Condition Malignant neoplasm of brain, Cancer (Pediatric), Metastatic Melanoma, cancers, malignant tumors, Non-Small Cell Lung Cancer, Melanoma, Cancer/Tumors, Cancer, Brain Cancer, Brain Tumor, malignancies, malignancy, brain tumors, malignant tumor, Malignant Melanoma, Ewing's Family Tumors, Brain Tumor (Pediatric), melanoma, Neoplasms
Treatment Midazolam, Binimetinib, PF-07284890
Clinical Study IdentifierNCT04543188
SponsorPfizer
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 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 or NSCLC 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
Cohort 6 (DDI Sub-study): 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
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