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
Pfizer
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 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.
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
This study is seeking participants who meet the following key eligibility criteria: 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 rece…
Interventions
- DrugPF-07799933
Tablet
- Drugbinimetinib
Tablet
- Biologicalcetuximab
Injection for intravenous use
- Drugmidazolam
syrup
- Drugfluorouracil
Injection for intravenous use
- Drugleucovorin
Injection for intravenous use
- Drugoxaliplatin
Injection for intravenous use
Locations (18)
- UCHealth Sue Anschutz-Rodgers Eye CenterAurora, Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Aurora, Colorado
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Aurora, Colorado
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Aurora, Colorado
- University of Miami Hospital and ClinicsMiami, Florida
- DFCI Chestnut HillNewton, Massachusetts