A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
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
2 other identifiers
interventional
148
7 countries
66
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2022
Longer than P75 for phase_1
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 1, 2026
August 1, 2026
4.8 years
September 9, 2022
August 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
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)
Cycle 1 (21 days)
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
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
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Baseline to 28 days after last dose of study treatment
Phase 1b Dose Expansion: Overall response rate (ORR)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years
Secondary Outcomes (13)
Phase 1a monotherapy and Phase 1b combination dose escalation: ORR
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs)
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities
Baseline to 2 years
Phase 1b Dose Expansion: Duration of Response (Overall and in CNS)
Baseline to 2 years
- +8 more secondary outcomes
Study Arms (3)
Phase 1a Monotherapy Dose Escalation
EXPERIMENTALParticipants will receive PF-07799544
Phase 1b Combination Dose Escalation
EXPERIMENTALParticipants will receive PF-07799544 and PF-07799933
Phase 1b Combination Dose Expansion
EXPERIMENTALParticipants will receive PF-07799544 and PF-07799933
Interventions
Tablet
Tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (66)
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham - Phase I Clinical Trials Unit
Birmingham, Alabama, 35249, United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
Los Angeles, California, 90025, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143, United States
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158, United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Moffitt McKinley Hospital
Tampa, Florida, 33612, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
MSK Basking Ridge.
Basking Ridge, New Jersey, 07920, United States
MSK Monmouth.
Middletown, New Jersey, 07748, United States
MSK Bergen.
Montvale, New Jersey, 07645, United States
MSK Commack.
Commack, New York, 11725, United States
MSK Westchester.
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, 10022, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Columbia University Medical Center - Neurological Institute of New York
New York, New York, 10032, United States
CUIMC Research Pharmacy
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065, United States
MSK Nassau.
Uniondale, New York, 11553, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501001, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, 09541-270, Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Alberta Health Services and The Governors of The University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Soroka Medical Center
Beersheba, Southern District, 8410101, Israel
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 13, 2022
Study Start
November 30, 2022
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
September 1, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.