A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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 (called binimetinib) 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. 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• 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 and Part 2).
• Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies
Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Highlands Oncology Group
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
Colorado
Clinical and Translational Research Center (CTRC)
RECRUITING
Aurora
UCHealth Sue Anschutz-Rodgers Eye Center
RECRUITING
Aurora
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
RECRUITING
Aurora
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
RECRUITING
Aurora
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
RECRUITING
Aurora
Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center
RECRUITING
Miami
University of Miami Sylvester Comprehensive Cancer Center-The Griffin Research Building
RECRUITING
Miami
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
DFCI Chestnut Hill
RECRUITING
Newton
Michigan
Brigitte Harris Cancer Pavilion
RECRUITING
Detroit
Henry Ford Hospital
RECRUITING
Detroit
Henry Ford Medical Center - Columbus
RECRUITING
Novi
CT Scan and Echo Only: Henry Ford Medical Center-Plymouth
RECRUITING
Plymouth
New Jersey
MSK Monmouth
RECRUITING
Middletown
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Cancer Center 53rd street
RECRUITING
New York
MSK David H. Koch Center for Cancer Care
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
RECRUITING
Cleveland
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Tennessee
Sarah Cannon Research Institute - Pharmacy
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
TriStar Bone Marrow Transplant
RECRUITING
Nashville
TriStar Centennial Medical center
RECRUITING
Nashville
TriStar Centennial Medical Center - Cell Processing Lab