NCT05355701Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 103 (actual)
- First submitted
- 26 Apr 2022
- Start date
- 5 Jul 2022
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Pfizer
- NCT number
- NCT05355701
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 103
- From 5 Jul 2022 to the primary completion date, 31 Aug 2027
- 40 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).
Other illness
- Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.
Other
- Brain metastasis larger than 4 cm
Who the study is looking for
- 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 received specific prior approved therapies
- Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.
- Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor/EGFR inhibitor allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
- Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor/EGFR inhibitors allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
Criteria the registry did not label
- This study is seeking participants who meet the following key eligibility criteria:
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital - General Campus Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| UCHealth Sue Anschutz-Rodgers Eye Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Clinical and Translational Research Center (CTRC) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Brigitte Harris Cancer Pavilion Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Highlands Oncology Group, PA Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| Sylvester Comprehensive Cancer Center* Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Miami Hospital and Clinics Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| MSK Monmouth. Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Sarah Cannon Research Institute- Pharmacy Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| TriStar Centennial Medical Center - Cell Processing Lab Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| TriStar Bone Marrow Transplant Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| TriStar Centennial Medical center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Dana-Farber Cancer Institute - Chestnut Hill Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center 53rd street. Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| MSK David H. Koch Center for Cancer Care Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Henry Ford Medical Center-Columbus Coordinator of this site? Confirm its status | Novi | United States | Unknown status |
| CT Scan and Echo Only: Henry Ford Medical Center-Plymouth Coordinator of this site? Confirm its status | Plymouth | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Cancer Institute Franz Clinic Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Highlands Oncology Group, PA Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Highlands Oncology Group, PA Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.