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A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

NCT05538130 · Pfizer
In plain English

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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
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 124 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2022-11-30
Estimated completion: 2028-11-24
Last updated: 2026-03-27
Interventions
Drug: PF-07799544Drug: PF-07799933
Primary outcomes
  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) (Cycle 1 (21 days))
  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs) (Baseline to 28 days after last dose of study medication)
  • Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities (Baseline to 28 days after last dose of study treatment)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (79)
The Kirklin Clinic of UAB HospitalNot Yet Recruiting
Birmingham, Alabama, United States
The University of Alabama at BirminghamNot Yet Recruiting
Birmingham, Alabama, United States
University of Alabama at Birmingham - Phase I Clinical Trials UnitNot Yet Recruiting
Birmingham, Alabama, United States
Highlands Oncology Group, PARecruiting
Fayetteville, Arkansas, United States
Highlands Oncology Group, PARecruiting
Rogers, Arkansas, United States
Highlands Oncology Group, PARecruiting
Springdale, Arkansas, United States
The Angeles Clinic and Research Institute- A Cedars-Sinai AffiliateRecruiting
Los Angeles, California, United States
Keck Hospital of USCNot Yet Recruiting
Los Angeles, California, United States
Los Angeles General Medical CenterNot Yet Recruiting
Los Angeles, California, United States
USC/Norris Comprehensive Cancer CenterNot Yet Recruiting
Los Angeles, California, United States
Keck Medical Center of USC PasadenaNot Yet Recruiting
Pasadena, California, United States
UCSF Helen Diller Medical Center at Parnassus HeightsRecruiting
San Francisco, California, United States
UCSF Medical Center, Investigational PharmacyRecruiting
San Francisco, California, United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)Recruiting
Santa Monica, California, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient CenterRecruiting
Tampa, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Moffitt McKinley HospitalRecruiting
Tampa, Florida, United States
Ochsner Clinic FoundationNot Yet Recruiting
New Orleans, Louisiana, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Brigitte Harris Cancer PavilionRecruiting
Detroit, Michigan, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
HealthPartners Frauenshuh Cancer CenterNot Yet Recruiting
Saint Louis Park, Minnesota, United States
Methodist Hospital Inpatient PharmacyNot Yet Recruiting
Saint Louis Park, Minnesota, United States
HealthPartners Cancer Center at regions HospitalNot Yet Recruiting
Saint Paul, Minnesota, United States
Regions Hospital PharmacyNot Yet Recruiting
Saint Paul, Minnesota, United States
MSK Basking Ridge.Recruiting
Basking Ridge, New Jersey, United States
MSK Monmouth.Recruiting
Middletown, New Jersey, United States
MSK Bergen.Recruiting
Montvale, New Jersey, United States
Optum Medical Care, PCNot Yet Recruiting
Brewster, New York, United States
MSK Commack.Recruiting
Commack, New York, United States
MSK Westchester.Recruiting
Harrison, New York, United States
Laura & Isaac Perlmutter Cancer Center - NYU ACCRecruiting
New York, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
NYU Langone Faculty Group PracticeRecruiting
New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center 53rd street.Recruiting
New York, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Columbia University Medical Center - Neurological Institute of New YorkRecruiting
New York, New York, United States
CUIMC Research PharmacyRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main CampusRecruiting
New York, New York, United States
Brooklyn Radiation Oncology, PCNot Yet Recruiting
Richmond Hill, New York, United States
MSK Nassau.Recruiting
Uniondale, New York, United States
Clinical Research AllianceNot Yet Recruiting
Westbury, New York, United States
Cleveland Clinic Taussig Cancer Center Investigational PharmacyRecruiting
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer CenterRecruiting
Cleveland, Ohio, United States
Providence Cancer Institute Franz ClinicRecruiting
Portland, Oregon, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
UPMC Hillman Cancer CenterNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute- PharmacyRecruiting
Nashville, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterRecruiting
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University HospitalRecruiting
Madison, Wisconsin, United States
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Royal Melbourne HospitalRecruiting
Parkville, Victoria, Australia
ANIMI - Unidade de Tratamento OncologicoRecruiting
Lages, Santa Catarina, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do SulRecruiting
São Caetano do Sul, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e EnsinoRecruiting
São Paulo, Brazil
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
Alberta Health Services and The Governors of The University of AlbertaRecruiting
Edmonton, Alberta, Canada
The Ottawa Hospital - General CampusRecruiting
Ottawa, Ontario, Canada
Sunnybrook Research InstituteRecruiting
Toronto, Ontario, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
McGill University Health CentreRecruiting
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-JésusRecruiting
Québec, Quebec, Canada
Zhejiang Cancer HospitalNot Yet Recruiting
Hangzhou, Zhejiang, China
Rabin Medical CenterRecruiting
Petah Tikva, Central District, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Central District, Israel
Hadassah Medical CenterNot Yet Recruiting
Jerusalem, Jerusalem, Israel
Soroka Medical CenterRecruiting
Beersheba, Southern District, Israel
Sourasky Medical CenterRecruiting
Tel Aviv, TELL ABĪB, Israel
National Cancer Center Hospital EastNot Yet Recruiting
Kashiwa, Chiba, Japan
Kansai Medical University HospitalNot Yet Recruiting
Hirakata, Osaka, Japan
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors · TrialPath