> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-study-medicine-called-pf-07799933-559e05cc-ad59-407c-b089-65dfdc2f4811 > Record changed: 2026-10-13 # A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. NCT05355701 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) Participants 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) Start date 2022-07-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) Number of sites 40 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Short title** A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Official title** 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](https://clinicaltrials.gov/study/NCT05355701) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Dates **Completion date** 2029-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **First posted** 2022-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Primary completion date** 2028-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Start date** 2022-07-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Size and sites **Participants** 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Planned participants** 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Number of sites** 40 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Identifiers **Registry ID** NCT05355701 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **ClinicalTrials.gov ID** NCT05355701 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Outcomes ### Primary outcomes 1. Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2) Timeframe: Cycle 1 (21 days) DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab 2. Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2) Timeframe: Baseline to 28 days after last dose of study medication AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy 3. Number of participants with clinically significant change from baseline in laboratory abnormalities (Part 1 and Part 2) Timeframe: Baseline to 28 days after last dose of study treatment Laboratory abnormalities as characterized by type, frequency, severity, and timing 4. Number of participants with clinically significant change from baseline in vital sign abnormalities (Part 1 and Part 2) Timeframe: Baseline to 28 days after last dose of study treatment Vital sign abnormalities as characterized by type, frequency, severity, and timing 5. Dose interruptions due to AEs (Part 1 and Part 2) Timeframe: Baseline to 2 years Incidence of dose interruptions due to AEs 6. Dose dose modifications due to AEs (Part 1 and Part 2) Timeframe: Baseline to 2 years Incidence of dose modifications due to AEs 7. Discontinuations due to AEs (Part 1 and Part 2) Timeframe: Baseline to 2 years Incidence of discontinuations due to AEs 8. Overall response rate (ORR) (Part 3) Timeframe: Baseline to 2 years Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 9. Number of participants with clinically significant physical exam abnormalities (Part 1 and Part 2) Timeframe: Baseline to 28 days after last dose of study treatment Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 ### Secondary outcomes 1. Part 1 and Part 2: ORR Timeframe: Baseline to 2 years ORR as assessed using the RECIST version 1.1. 2. Part 1/2/3: Intracranial response Timeframe: Baseline to 2 years Intracranial response by RECIST version 1.1 (for brain metastases) \\& Response Assessment in Neuro-Oncology (RANO) - for primary brain tumors). 3. Part 1 and Part 2: Duration of response Timeframe: Baseline to 2 years Duration of response 4. Part 3: Number of participants with treatment-emergent adverse events (AEs) Timeframe: Baseline to 2 years AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy 5. Part 3: Number of participants with clinically significant change from baseline in laboratory abnormalities Timeframe: Baseline to 2 years Laboratory abnormalities as characterized by type, frequency, severity, and timing 6. Part 3: Number of participants with clinically significant change from baseline in vital sign abnormalities Timeframe: Baseline to 2 years Vital sign abnormalities as characterized by type, frequency, severity, and timing 7. Part 3: Dose interruptions due to AEs Timeframe: Baseline to 2 years Incidence of dose interruptions due to AEs 8. Part 3: Dose dose modifications due to AEs Timeframe: Baseline to 2 years Incidence of dose modifications due to AEs 9. Part 3: Discontinuations due to AEs Timeframe: Baseline to 2 years Incidence of discontinuations due to AEs 10. Part 3: Time to event endpoints in each combination Timeframe: Baseline to 2 years Time to event endpoints in each combination 11. Part 3: Disease Control Rate (DCR) Timeframe: Baseline to 2 years DCR 12. Part 1/2/3: PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, Cmax 13. Part 1/2/3: PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, Tmax 14. Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, AUClast 15. Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 24 hours (AUC24) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, AUC24 16. Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 48 hours (AUC48) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, AUC48 17. Part 1/2/3: PK parameters of PF-07799933, Single dose, terminal elimination half life (t½) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, t½ 18. Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, AUCinf 19. Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, CL/F 20. Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Single dose, Vz/F 21. Part 1/2/3: PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Multiple dose, Cmax 22. Part 1/2/3: PK parameters of PF-07799933, Multiple dose, trough plasma or serum concentration (Ctrough) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Multiple dose, Ctrough 23. Part 1/2/3: PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Multiple dose, Tmax 24. Part 1/2/3: PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ) Timeframe: Baseline to 2 years PK parameters of PF-07799933, Multiple dose, AUCτ 25. Part 1/2/3: PK parameters of PF-07799933, Multiple dose, CL/F Timeframe: Baseline to 2 years PK parameters of PF-07799933, Multiple dose, CL/F And 17 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 16 Years **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 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. ### Exclusion criteria - Brain metastasis larger than 4 cm - 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. - Concurrent neuromuscular disorder associated with elevated creatine kinase (CK). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Sites - Highlands Oncology Group, PAFayetteville, United StatesRecruiting - Highlands Oncology Group, PARogers, United StatesRecruiting - Highlands Oncology Group, PASpringdale, United StatesRecruiting - Clinical and Translational Research Center (CTRC)Aurora, United StatesRecruiting - UCHealth Sue Anschutz-Rodgers Eye CenterAurora, United StatesRecruiting - University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Aurora, United StatesRecruiting - University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Aurora, United StatesRecruiting - University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Aurora, United StatesRecruiting - Sylvester Comprehensive Cancer CenterMiami, United StatesRecruiting - University of Miami Hospital and ClinicsMiami, United StatesRecruiting - Brigham and Women's HospitalBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Dana-Farber Cancer Institute - Chestnut HillNewton, United StatesRecruiting - Brigitte Harris Cancer PavilionDetroit, United StatesRecruiting - Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)Detroit, United StatesRecruiting - Henry Ford Medical Center - ColumbusNovi, United StatesRecruiting - CT Scan and Echo Only: Henry Ford Medical Center-PlymouthPlymouth, United StatesRecruiting - MSK MonmouthMiddletown, United StatesRecruiting - MSK David H. Koch Center for Cancer CareNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer Center 53rd streetNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Cleveland Clinic Taussig Cancer Center Investigational PharmacyCleveland, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - Providence Cancer Institute Franz ClinicPortland, United StatesRecruiting - Providence Portland Medical CenterPortland, United StatesRecruiting And 15 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4761001) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05355701) ## Related records ### Drugs (7) - [Binimetinib](https://trialight.com/data/asset/binimetinib-f5914744-65e2-4d8c-8482-9f51a406315e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Claturafenib](https://trialight.com/data/asset/claturafenib-3f3b1d4c-4f11-400b-920c-445813e0e315.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Midazolam](https://trialight.com/data/asset/midazolam-1bd7ce5f-a598-4c40-a36b-e990c47207ef.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (6) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Glioma](https://trialight.com/data/condition/glioma-4ac240c4-7ffb-5f08-b793-0b205a4b5d03.md) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Primary condition - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Thyroid cancer](https://trialight.com/data/condition/thyroid-cancer-44afb6a8-b88e-5e18-b9fd-7b51661c2c23.md) - [Thyroid tumor](https://trialight.com/data/condition/thyroid-tumor-fc2bab9d-d468-5acb-8a62-e5f68e538979.md) ### Targets (20) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) - [MAP2K1](https://trialight.com/data/target/map2k1-4497ab8d-b990-5d3e-8e15-5320bf37cb8d.md) - [MAP2K2](https://trialight.com/data/target/map2k2-5231fae9-faf4-5f98-96f9-403a8160886d.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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