PF-07284892 in Participants With Advanced Solid Tumors
Reason given: The study was prematurely discontinued due to strategic reasons. The PF-07284892 program will continue
Key facts
- Where
- Detroit, Franklin, Grand Rapids, Houston, Nashville, New York, Novi, Phoenix, and Scottsdale, United StatesSee the 11 sites
- Phase
- Phase 1
Where in United States
- Brigitte Harris Cancer PavilionDetroit, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- Tennessee Oncology, PLLCFranklin, United StatesNo longer taking part
- START | MidwestGrand Rapids, United StatesNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- SCRI Oncology PartnersNashville, United StatesNo longer taking part
- Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer CareNew York, United StatesNo longer taking part
- Memorial Sloan Kettering Cancer Center Rockefeller Outpatient PavilionNew York, United StatesNo longer taking part
- Henry Ford Medical Center-ColumbusNovi, United StatesNo longer taking part
- Mayo Clinic in Arizona - PhoenixPhoenix, United StatesNo longer taking part
- Mayo ClinicScottsdale, United StatesNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT04800822EU 2022-502431-18-00
- Record updated
- 4 June 2026
- Original description
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.Read full original descriptionShow less
A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EVIDENCE OF ANTI-TUMOR ACTIVITY OF PF-07284892 (ARRY-558) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
Inclusion: Age ≥18 years at the time of informed consent; Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor. Participants with ROS-positive NSCLC are also eligible for Part 1 and 2 (Other ROS1-positive solid tumors may be considered after discussion with the sponsor); Documentation evidence of biomarker mutation status; Part 3:; ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort 1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no prior lorlatinib (Cohort 3); BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6); RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC (Cohort 7).
Exclusion: Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to start of study treatment. Antibody based agents within 4 weeks prior to start of study treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study treatment; For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK); Active malignancy within 3 years; For participants who may get lorlatinib or encorafenib on study, history of interstitial lung disease; Brain metastasis larger than 4 cm.