NCT05355701 · Pfizer
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
What this study is about
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors.
View original scientific description
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: * People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. * People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Interventions
DRUG
PF-07799933
Tablet
DRUG
binimetinib
Tablet
BIOLOGICAL
cetuximab
Injection for intravenous use
DRUG
midazolam
syrup
DRUG
fluorouracil
Injection for intravenous use
DRUG
leucovorin
Injection for intravenous use
DRUG
oxaliplatin
Injection for intravenous use
Primary outcome measures
Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to 2 years
Incidence of dose interruptions due to AEs
Dose dose modifications due to AEs (Part 1 and Part 2)
Time frame: Baseline to 2 years
Incidence of dose modifications due to AEs
Discontinuations due to AEs (Part 1 and Part 2)
Time frame: Baseline to 2 years
Incidence of discontinuations due to AEs
Overall response rate (ORR) (Part 3)
Time frame: 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)
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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).
Where
- Fayetteville, Arkansas
- Rogers, Arkansas
- Springdale, Arkansas
- Aurora, Colorado
- Miami, Florida
- Boston, Massachusetts
- Newton, Massachusetts
- Detroit, Michigan
- Novi, Michigan
- Plymouth, Michigan
- Middletown, New Jersey
- New York, New York
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations