A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF 07284890 (ARRY 461) IN PARTICIPANTS WITH BRAF V600 MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT
Description
Brief 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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
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