A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
NCT ID: NCT05355701
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
156 participants
INTERVENTIONAL
2022-07-05
2028-09-28
Brief Summary
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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. 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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy dose escalation (Part 1)
Participants will receive PF-07799933
PF-07799933
Tablet
Combination dose escalation (Part 2)
Participants will receive PF-07799933 in combination with binimetinib or cetuximab
PF-07799933
Tablet
binimetinib
Tablet
cetuximab
Injection for intravenous use
Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
Participants will receive PF-07799933
PF-07799933
Tablet
Dose expansion (Part 3) - Tumor and mutation specific Cohort 2
Participants will receive PF-07799933
PF-07799933
Tablet
binimetinib
Tablet
Interventions
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PF-07799933
Tablet
binimetinib
Tablet
cetuximab
Injection for intravenous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 and Part 2).
* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies
Exclusion Criteria
* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
* For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Clinical and Translational Research Center (CTRC)
Aurora, Colorado, United States
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center-The Griffin Research Building
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
DFCI Chestnut Hill
Newton, Massachusetts, United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
CT Scan and Echo Only: Henry Ford Medical Center-Plymouth
Plymouth, Michigan, United States
MSK Monmouth
Middletown, New Jersey, United States
MSK David H. Koch Center for Cancer Care
New York, New York, United States
Memorial Sloan Kettering Cancer Center 53rd street
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennesse Oncology, PLLC
Nashville, Tennessee, United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States
TriStar Centennial Medical Center - Cell Processing Lab
Nashville, Tennessee, United States
TriStar Centennial Medical center
Nashville, Tennessee, United States
START San Antonio
San Antonio, Texas, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Sheba Medical Center
Ramat Gan, Central District, Israel
Sourasky Medical Center
Tel Aviv, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Ḥeifā, Israel
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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BRAF Class 2
Identifier Type: OTHER
Identifier Source: secondary_id
C4761001
Identifier Type: -
Identifier Source: org_study_id