What is PF-07799933 studying for advanced solid tumors with BRAF alterations?

PF-07799933 is being studied to learn about its safety and effects alone and combined with other medicines in people with advanced solid tumors that have a specific BRAF gene change. This research aims to find new options for patients whose cancers have progressed despite current treatments. The study is sponsored by Pfizer to better understand this medicine's impact in this patient group.

Who may be eligible for this advanced solid tumor clinical trial?

People 16 years and older with advanced or metastatic solid tumors that have certain BRAF gene alterations may be eligible. Participants should have tumors that have progressed after prior treatments and no satisfactory options remain. Both males and females can join. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, participants may need to cover their own travel and related expenses, which can vary. Planning ahead for travel costs is advised when considering participation.

Actively Recruiting

Phase 1

Age: 16Years +

All Genders

ID05355701

A Phase 1 Study to Evaluate the Safety and Effects of PF-07799933 Alone and with Other Medicines in People 16 Years and Older with Advanced Solid Tumors with BRAF Gene Changes

Led by Pfizer · Updated on 2026-06-05

267

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effects of a medicine called PF-07799933 for people 16 years and older who have advanced solid tumors with a specific abnormal gene called BRAF. This study focuses on participants whose cancers have progressed despite available treatments. It is a phase 1, open-label trial sponsored by Pfizer to evaluate the tolerability, pharmacokinetics, and anti-tumor activity of PF-07799933 alone and in combination with other medicines. All participants will receive PF-07799933 tablets twice daily. Depending on the tumor type, some may also receive other study medicines: binimetinib tablets twice daily for melanoma or other solid tumors; or cetuximab injections weekly or every two weeks, alone or combined with chemotherapy (mFOLFOX6), for colorectal cancer. The study includes dose escalation and expansion parts to assess different combinations and doses. Participants may receive treatment for about two years with regular clinic visits for monitoring. Researchers will assess side effects, laboratory results, vital signs, physical exams, and tumor responses over time. They will also study how the drug is processed in the body. The study monitors dose changes, interruptions, and discontinuations related to treatment-emergent adverse events, aiming to understand safety and effectiveness in this patient group.

CONDITIONS

Brief 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 gene alteration (V600 or non-V600 Class II/Class III) in tumor tissue or blood
Disease progressed after prior treatment with no satisfactory alternative options (for Parts 1, 2, and certain Part 3 cohorts)
Specific prior therapies required for tumor-specific cohorts (melanoma, colorectal cancer)
For Part 3 Cohort 1 (BRAF V600 mutant melanoma): prior BRAF V600 inhibitor, MEK inhibitor, and immune checkpoint inhibitor therapies required
For Part 3 Cohort 4 (BRAF V600E colorectal cancer): at least 2 cycles of prior 5-FU based chemotherapy, no prior BRAF or EGFR inhibitor, and prior immune checkpoint inhibitor if MSI-H/dMMR
For Part 3 Cohort 5 (BRAF V600E colorectal cancer): no more than 2 cycles of prior 5-FU chemotherapy, no prior BRAF or EGFR inhibitors, and prior immune checkpoint inhibitor if MSI-H/dMMR

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 21-day cycles until disease progression or discontinuation

Participants receive the study medicine PF-07799933 alone or in combination with other medicines depending on their cohort assignment.

Multiple visits each cycle for treatment and assessments

Follow-up

Duration - Up to 28 days after last dose of study medication

Participants are monitored for safety and treatment effects after completing treatment.

Approximately 1 to 2 visits post-treatment

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