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

Actively Recruiting

Phase 1

Age: 16Years +

All Genders

NCT05355701

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

Led by Pfizer · Updated on 2026-05-14

267

Participants Needed

Research Sites

422 weeks

Total Duration

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of advanced or metastatic solid tumor including primary brain tumor
Presence of qualifying BRAF alteration (V600 or non-V600 Class II/Class III) in tumor tissue or blood
Disease progression after last prior treatment with no satisfactory alternative options
Tumor-specific prior therapies required for melanoma and colorectal cancer cohorts
Prior BRAF V600 inhibitor, MEK inhibitor, and immune checkpoint inhibitor therapy required for BRAF V600 mutant melanoma (Part 3 Cohort 1)
Minimum of 2 cycles of prior 5-FU chemotherapy required for BRAF V600E colorectal cancer without prior BRAF/EGFR inhibitors (Part 3 Cohort 4)
No more than 2 cycles of prior 5-FU chemotherapy allowed for BRAF V600E colorectal cancer without prior BRAF/EGFR inhibitors (Part 3 Cohort 5)
Prior immune checkpoint inhibitor therapy required for MSI-H/dMMR metastatic colorectal cancer participants

You will not qualify if you...

Brain metastasis larger than 4 cm
Ongoing systemic anti-cancer therapy or small molecule therapeutics at study start
History or current retinal vein occlusion or retinal degenerative disease
Current risk factors for retinal vein occlusion
Neuromuscular disorders associated with elevated creatine kinase

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Trial Site Locations

Total: 40 locations

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

Actively Recruiting

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

Actively Recruiting

Clinical and Translational Research Center (CTRC)

Aurora, Colorado, United States, 80045

Actively Recruiting

UCHealth Sue Anschutz-Rodgers Eye Center

Aurora, Colorado, United States, 80045

Actively Recruiting

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

Actively Recruiting

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States, 80045

Actively Recruiting

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, United States, 80045

Actively Recruiting

Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

Actively Recruiting

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

DFCI Chestnut Hill

Newton, Massachusetts, United States, 02459

Actively Recruiting

Brigitte Harris Cancer Pavilion

Detroit, Michigan, United States, 48202

Actively Recruiting

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

Henry Ford Medical Center - Columbus

Novi, Michigan, United States, 48377

Actively Recruiting

CT Scan and Echo Only: Henry Ford Medical Center-Plymouth

Plymouth, Michigan, United States, 48170

Actively Recruiting

MSK Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

MSK David H. Koch Center for Cancer Care

New York, New York, United States, 10021

Actively Recruiting

Memorial Sloan Kettering Cancer Center 53rd street

New York, New York, United States, 10022

Actively Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, United States, 44106

Actively Recruiting

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

Actively Recruiting

Providence Portland Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

Sarah Cannon Research Institute - Pharmacy