A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
Recruiting · NCT05538130 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
PF-07799544PF-07799933
What this trial is about
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.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 17 US states.
- The Kirklin Clinic of UAB Hospital - Birmingham, Alabama, United States
- The University of Alabama at Birmingham - Birmingham, Alabama, United States
- University of Alabama at Birmingham - Phase I Clinical Trials Unit - Birmingham, Alabama, United States
- Highlands Oncology Group, PA - Fayetteville, Arkansas, United States
- Highlands Oncology Group, PA - Rogers, Arkansas, United States
- Highlands Oncology Group, PA - Springdale, Arkansas, United States
- The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate - Los Angeles, California, United States
- Keck Hospital of USC - Los Angeles, California, United States
- Los Angeles General Medical Center - Los Angeles, California, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Keck Medical Center of USC Pasadena - Pasadena, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco, California, United States
- UCSF Helen Diller Medical Center at Parnassus Heights - San Francisco, California, United States
- UCSF Medical Center, Investigational Pharmacy - San Francisco, California, United States
- The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only) - Santa Monica, California, United States
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt McKinley Hospital - Tampa, Florida, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Ophthalmic Consultants of Boston Inc (OCB) - Boston, Massachusetts, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Mass General Waltham - Waltham, Massachusetts, United States
- Brigitte Harris Cancer Pavilion - Detroit, Michigan, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- HealthPartners Frauenshuh Cancer Center - Saint Louis Park, Minnesota, United States
- Methodist Hospital Inpatient Pharmacy - Saint Louis Park, Minnesota, United States
- HealthPartners Cancer Center at regions Hospital - Saint Paul, Minnesota, United States
- Regions Hospital Pharmacy - Saint Paul, Minnesota, United States
- MSK Basking Ridge. - Basking Ridge, New Jersey, United States
- MSK Monmouth. - Middletown, New Jersey, United States
- MSK Bergen. - Montvale, New Jersey, United States
- Optum Medical Care, PC - Brewster, New York, United States
- MSK Commack. - Commack, New York, United States
- MSK Westchester. - Harrison, New York, United States
- Optum Medical Care, PC - Mount Kisco, New York, United States
- Laura & Isaac Perlmutter Cancer Center - NYU ACC - New York, New York, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York, New York, United States
- NYU Langone Faculty Group Practice - New York, New York, United States
- NYU Langone Medical Center (Tisch Hospital) - New York, New York, United States
- Memorial Sloan Kettering Cancer Center 53rd street. - New York, New York, United States
- Columbia University Irving Medical Center - New York, New York, United States
- Columbia University Medical Center - Neurological Institute of New York - New York, New York, United States
- CUIMC Research Pharmacy - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - Main Campus - New York, New York, United States
- MSK Nassau. - Uniondale, New York, United States
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy - Cleveland, Ohio, United States
- Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio, United States
- Providence Cancer Institute Franz Clinic - Portland, Oregon, United States
- Providence Portland Medical Center - Portland, Oregon, United States
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- University of Washington Medical Center - Seattle, Washington, United States
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center - Madison, Wisconsin, United States
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison, Wisconsin, United States
- Centro de Oncologia - CEON+ - Unidade São Caetano do Sul - São Caetano do Sul, Brazil
- IBCC - Núcleo de Pesquisa e Ensino - São Paulo, Brazil
Showing 60 of 83 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →