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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

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jewish General Hospital
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MontrealCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
The Ottawa Hospital - General Campus
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OttawaCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
University Health Network
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TorontoCanadaUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky Medical Center
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Tel AvivIsraelUnknown status
UCHealth Sue Anschutz-Rodgers Eye Center
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AuroraUnited StatesUnknown status
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
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AuroraUnited StatesUnknown status
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
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AuroraUnited StatesUnknown status
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
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AuroraUnited StatesUnknown status
Clinical and Translational Research Center (CTRC)
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AuroraUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
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ClevelandUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
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DetroitUnited StatesUnknown status
Brigitte Harris Cancer Pavilion
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DetroitUnited StatesUnknown status
Highlands Oncology Group, PA
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FayettevilleUnited StatesUnknown status
Sylvester Comprehensive Cancer Center*
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MiamiUnited StatesUnknown status
University of Miami Hospital and Clinics
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MiamiUnited StatesUnknown status
MSK Monmouth.
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MiddletownUnited StatesUnknown status
Sarah Cannon Research Institute- Pharmacy
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NashvilleUnited StatesUnknown status
TriStar Centennial Medical Center - Cell Processing Lab
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NashvilleUnited StatesUnknown status
SCRI Oncology Partners
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NashvilleUnited StatesUnknown status
TriStar Bone Marrow Transplant
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NashvilleUnited StatesUnknown status
TriStar Centennial Medical center
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NashvilleUnited StatesUnknown status
Dana-Farber Cancer Institute - Chestnut Hill
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NewtonUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center 53rd street.
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
MSK David H. Koch Center for Cancer Care
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New YorkUnited StatesUnknown status
Henry Ford Medical Center-Columbus
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NoviUnited StatesUnknown status
CT Scan and Echo Only: Henry Ford Medical Center-Plymouth
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PlymouthUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Providence Cancer Institute Franz Clinic
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PortlandUnited StatesUnknown status
Highlands Oncology Group, PA
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RogersUnited StatesUnknown status
START | San Antonio
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San AntonioUnited StatesUnknown status
Highlands Oncology Group, PA
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SpringdaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.