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PF-07799933 for Advanced Solid Tumors with BRAF Alterations

This study is testing PF-07799933, a tablet taken twice daily, for people with advanced solid tumors that have a specific gene change called a "BRAF alteration." This includes cancers like melanoma, non-small cell lung cancer, thyroid cancer, glioma, and advanced colorectal cancer, especially when other treatments haven't worked. Some participants, particularly those with melanoma, may also receive binimetinib, another tablet. The main goals are to understand the safety of PF-07799933, alone and with other medicines, by tracking side effects and changes in lab tests for up to 28 days after the last dose. The study aims to enroll 267 participants.

Study design
This interventional study is exploring PF-07799933, alone or with other medicines, in 267 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects and lab changes for up to 28 days after their last dose of study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05355701

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

Recruiting
PHASE1Ages 16+InterventionalTreatment
Pfizer
~267 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:PF-07799933binimetinibcetuximabmidazolamfluorouracilleucovorin

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)
Measured over Cycle 1 (21 days)
+8 more outcomes measured

Conditions

Melanoma
Non-Small-Cell Lung Cancer
Thyroid Cancer
Glioma
Advanced Colorectal Cancer (Part 1)

Explore related trials

Colorectal CarcinomaGliomaLung Non-Small Cell CarcinomaMelanomaSolid NeoplasmThyroid Gland Carcinoma

Where it's being run

40 sites across 16 states
Colorado5
Tennessee5
Michigan4
Arkansas3
Massachusetts3
New York3
Ontario3
Florida2

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of advanced/metastatic solid tumor including primary brain tumor.
Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA).
Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).
Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies
Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.
Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor/EGFR inhibitor allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor/EGFR inhibitors allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.

Exclusion

Brain metastasis larger than 4 cm
Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.
Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).

What this trial measures

  • Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)Cycle 1 (21 days)

    DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab

  • Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2)Baseline to 28 days after last dose of study medication

    AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy

  • Number of participants with clinically significant change from baseline in laboratory abnormalities (Part 1 and Part 2)Baseline to 28 days after last dose of study treatment

    Laboratory abnormalities as characterized by type, frequency, severity, and timing

  • Number of participants with clinically significant change from baseline in vital sign abnormalities (Part 1 and Part 2)Baseline to 28 days after last dose of study treatment

    Vital sign abnormalities as characterized by type, frequency, severity, and timing

  • Dose interruptions due to AEs (Part 1 and Part 2)Baseline to 2 years

    Incidence of dose interruptions due to AEs

  • Dose dose modifications due to AEs (Part 1 and Part 2)Baseline to 2 years

    Incidence of dose modifications due to AEs

  • Discontinuations due to AEs (Part 1 and Part 2)Baseline to 2 years

    Incidence of discontinuations due to AEs

  • Overall response rate (ORR) (Part 3)Baseline to 2 years

    Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  • Number of participants with clinically significant physical exam abnormalities (Part 1 and Part 2)Baseline to 28 days after last dose of study treatment

    Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0