Stopped: Pfizer has made an internal business decision to not continue further development of PF-07284890. This decision was not due to major safety concerns or requests from any regulatory authorities.
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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Number of Participants With Dose Limiting Toxicities (DLTs): Phase 1a
Timeframe: Cycle 1 (21 Days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1a
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer therapy (-1 Day) whichever occurred first (maximum treatment exposure: 542 days; maximum follow-up: 572 days)
Number of Participants With Hematology Laboratory Abnormalities of Any CTCAE Grade: Phase 1a
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment (maximum treatment exposure: 542 days; maximum follow-up: 572 days)
Number of Participants With Chemistry Laboratory Abnormalities of Any CTCAE Grade: Phase 1a
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment (maximum treatment exposure: 542 days; maximum follow-up: 572 days)
Number of Participants With Dose Interruptions Due to TEAEs: Phase 1a
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 542 days])
Number of Participants With Dose Reduction Due to TEAEs: Phase 1a
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 542 days])
Number of Participants With Dose Discontinuations Due to TEAEs: Phase 1a
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 542 days])
Extracranial Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Phase 1b
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)
Intracranial Response Rate by mRECISTv1.1: Phase 1b
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)
Overall Response Rate (ORR): Phase 1b
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)
Response Rate Using Response Assessment in Neuro-Oncology (RANO) for Primary Brain Tumors: Phase 1b
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)