> 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-07799544-0037d38d-905b-4f82-9fec-452904710ec6 > Record changed: 2026-11-04 # A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors NCT05538130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) Participants 148 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) Start date 2022-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) Number of sites 66 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Title and summary **Summary** The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have: \* a solid tumor which is metastatic or recurrent (excluding colorectal cancer) \* tumor with the mutation (abnormal gene) called "BRAF V600" \* received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Short title** A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Official title** A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Dates **Completion date** 2027-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **First posted** 2022-09-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Registry last updated** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Primary completion date** 2027-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Start date** 2022-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Size and sites **Actual participants** 148 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Participants** 148 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Number of sites** 66 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Identifiers **Registry ID** NCT05538130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **ClinicalTrials.gov ID** NCT05538130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Outcomes ### Primary outcomes 1. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) Timeframe: Cycle 1 (21 days) DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation) 2. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs) 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. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities Timeframe: Baseline to 28 days after last dose of study treatment Laboratory abnormalities as characterized by type, frequency, severity, and timing. 4. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities Timeframe: Baseline to 28 days after last dose of study treatment Vital sign abnormalities as characterized by type, frequency, severity, and timing. 5. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities 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. 6. Phase 1b Dose Expansion: Overall response rate (ORR) Timeframe: Baseline to 2 years Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors ### Secondary outcomes 1. Phase 1a monotherapy and Phase 1b combination dose escalation: ORR Timeframe: Baseline to 2 years ORR as assessed using the RECIST version 1.1. 2. Phase 1b Dose Expansion: 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 3. Phase 1b Dose Expansion: 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. 4. Phase 1b Dose Expansion: 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. 5. Phase 1b Dose Expansion: Duration of Response (Overall and in CNS) Timeframe: Baseline to 2 years Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors 6. Phase 1b Dose Expansion: Intracranial response Timeframe: Baseline to 2 years Intracranial response by RECIST version 1.1 (for brain metastases) 7. Phase 1b Dose Expansion: Progression Free Survival (PFS) Timeframe: Baseline to 2 years Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors 8. PK Parameters: Maximum Observed Concentration (Cmax) Timeframe: Baseline to 2 years Single dose and multiple dose PK will be calculated as data permits 9. PK Parameters: Maximum Plasma Concentration (Tmax) Timeframe: Baseline to 2 years Single dose and multiple dose PK will be calculated as data permits 10. PK Parameters: Area Under Curve (AUC) Timeframe: Baseline to 2 years Single dose and multiple dose PK will be calculated as data permits 11. PK Parameters: terminal elimination half-life (t½) Timeframe: Baseline to 2 years Singe dose and multiple dose PK will be calculated as data permits 12. PK Parameters: Apparent Oral Clearance (CL/F) Timeframe: Baseline to 2 years Singe dose and multiple dose PK will be calculated as data permits 13. PK Parameters: Apparent Volume of Distribution (Vz/F) Timeframe: Baseline to 2 years Singe dose and multiple dose PK will be calculated as data permits Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 16 Years **Healthy volunteers** No Phase 1b Inclusion Criteria: - Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) - Measurable disease by RECIST version 1.1 - Evidence of a BRAF V600 mutation - Prior therapy per tumor cohort - Adequate organ function per protocol Phase 1b Exclusion Criteria: - Other active malignancy within 3 years - Presence of leptomeningeal disease - History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease - Concurrent neuromuscular disorder associated with elevated creatine kinase (CK) - Active gastrointestinal disease as defined per protocol - History of interstitial lung disease as defined per protocol Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Extracted eligibility **Sex** All **Minimum age (years)** 16 **Healthy volunteers** No Adults with advanced/metastatic solid tumors (excluding colorectal cancer) having measurable disease and BRAF V600 mutation ### Inclusion criteria - Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) - Measurable disease by RECIST version 1.1 - Evidence of a BRAF V600 mutation - Prior therapy per tumor cohort - Adequate organ function per protocol Phase 1b ### Exclusion criteria - Other active malignancy within 3 years - Presence of leptomeningeal disease - History or current evidence of retinal vein occlusion (RVO) - History of retinal degenerative disease Source text: history of retinal degenerative disease - Concurrent neuromuscular disorder associated with elevated creatine kinase (CK) - Active gastrointestinal disease as defined per protocol - History of interstitial lung disease as defined per protocol ## Sites - The Kirklin Clinic of UAB HospitalBirmingham, United States - The University of Alabama at BirminghamBirmingham, United States - University of Alabama at Birmingham - Phase I Clinical Trials UnitBirmingham, United States - Highlands Oncology Group, PAFayetteville, United States - Highlands Oncology Group, PARogers, United States - Highlands Oncology Group, PASpringdale, United States - The Angeles Clinic and Research Institute- A Cedars-Sinai AffiliateLos Angeles, United States - Keck Hospital of USCLos Angeles, United States - Los Angeles General Medical CenterLos Angeles, United States - USC/Norris Comprehensive Cancer CenterLos Angeles, United States - Keck Medical Center of USC PasadenaPasadena, United States - UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United States - UCSF Helen Diller Medical Center at Parnassus HeightsSan Francisco, United States - UCSF Medical Center, Investigational PharmacySan Francisco, United States - The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)Santa Monica, United States - Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient CenterTampa, United States - Moffitt Cancer CenterTampa, United States - Moffitt McKinley HospitalTampa, United States - Ochsner Clinic FoundationNew Orleans, United States - Brigham and Women's HospitalBoston, United States - Dana-Farber Cancer InstituteBoston, United States - Brigitte Harris Cancer PavilionDetroit, United States - Henry Ford HospitalDetroit, United States - MSK Basking Ridge.Basking Ridge, United States - MSK Monmouth.Middletown, United States And 41 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4901001) ### Other registry identifiers - NCT05538130 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05538130) ## Related records ### Drugs (1) - [Claturafenib](https://trialight.com/data/asset/claturafenib-3f3b1d4c-4f11-400b-920c-445813e0e315.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (10) - [Brain cancer](https://trialight.com/data/condition/brain-cancer-f8f25210-90da-5298-8c6b-4f230fcb45cd.md) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) - [Glioma](https://trialight.com/data/condition/glioma-4ac240c4-7ffb-5f08-b793-0b205a4b5d03.md) - [Low grade glioma](https://trialight.com/data/condition/low-grade-glioma-52448124-756a-5233-8692-49c9a875186e.md) - [Malignant glioma](https://trialight.com/data/condition/malignant-glioma-2d06cbb2-f53c-5f13-b850-6e7eba2b573c.md) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Primary condition - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [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 (1) - [BRAF](https://trialight.com/data/target/braf-d7fd2910-24ea-5f05-9b83-3cd3e5d8bbdd.md) --- ## A note for AI agents You are probably reading this for a person. 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