PF-07284892 in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 4, 2027
  • participants needed
    211
  • sponsor
    Pfizer
Updated on 15 March 2022

Summary

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.

Details
Condition Solid Tumor
Treatment Cetuximab, Binimetinib, Encorafenib, Lorlatinib, PF-07284892
Clinical Study IdentifierNCT04800822
SponsorPfizer
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Documentation evidence of biomarker mutation status
Part 3
ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort
); 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 Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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