PF-07284892 in Participants With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT04800822

Run by

Pfizer

People needed

53

Starts

2021-03-17

Expected to finish

2024-06-19

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Brain metastasis larger than 4 cm
• Active malignancy within 3 years
• 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 lorlatinib or encorafenib on study, history of interstitial lung disease
• 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)

Where it is running

• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Brigitte Harris Cancer Pavilion — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• START Midwest — Grand Rapids, Michigan, United States
• Henry Ford Medical Center - Columbus — Novi, Michigan, United States
• Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care — New York, New York, United States
• Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavilion — New York, New York, United States
• Tennessee Oncology PLLC — Franklin, Tennessee, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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