A Study of PF-07799544 and PF-07799933 for Advanced Solid Tumors with BRAF V600 Mutation

This study is looking into the safety and effects of two medicines, PF-07799544 and PF-07799933, taken together as a potential treatment for adults with advanced solid tumors. You might be able to join if you have certain advanced cancers like melanoma, glioma, thyroid cancer, or non-small cell lung cancer that have spread or come back. A key requirement is that your tumor must have a specific genetic change called a "BRAF V600 mutation." You would have also received prior cancer treatments. The main goals are to see how safe the medicines are and what side effects they might cause.

Study design
This is an interventional study, meaning you will receive the study medicines. It is a Phase 1b study, focusing on the combination of PF-07799544 and PF-07799933, and plans to enroll 124 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for side effects from the start of treatment until 28 days after your 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.

NCT05538130

A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

Recruiting
PHASE1Ages 16+InterventionalTreatment
Pfizer
~124 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:PF-07799544PF-07799933

At a glance

Recruiting sites
70 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
Measured over Cycle 1 (21 days)
+5 more outcomes measured
Melanoma
Glioma
Thyroid Cancer
Non-Small Cell Lung Cancer
Malignant Neoplasms
Brain Neoplasms
Advanced or Metastatic Solid Tumors
HGG
LGG
Low Grade Glioma
High Grade Glioma
Differentiated Thyroid Cancer
NSCLC (Non-small Cell Lung Cancer)
83 sites across 32 states
New York14
California9
Massachusetts5
Minnesota4
Alabama3
Arkansas3
Florida3
New Jersey3
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

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Eligibility criteria

Inclusion

Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
Measurable disease by RECIST version 1.1
Evidence of a BRAF V600 mutation
Prior therapy per tumor cohort
Adequate organ function per protocol

Exclusion

Other active malignancy within 3 years
Presence of leptomeningeal disease
History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Active gastrointestinal disease as defined per protocol
History of interstitial lung disease as defined per protocol
  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)Cycle 1 (21 days)

    DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)

  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)Baseline to 28 days after last dose of study medication

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

  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalitiesBaseline to 28 days after last dose of study treatment

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

  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalitiesBaseline to 28 days after last dose of study treatment

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

  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalitiesBaseline 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.

  • Phase 1b Dose Expansion: Overall response rate (ORR)Baseline to 2 years

    Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors