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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Phase 1b Who May Qualify: - 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests per protocol Phase 1b Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

PF-07799544

Tablet

DRUG

PF-07799933

Tablet

Locations (20)

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 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
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States