RecruitingPhase 1NCT05538130

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

Sponsor

Pfizer

Enrollment

124 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Melanoma Thyroid Cancer Glioma

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.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new drug called PF-07799544, either alone or combined with other drugs, in people with advanced solid tumors that carry a specific genetic mutation called BRAF V600. BRAF V600 mutations are found in several cancers (like melanoma, lung cancer, and thyroid cancer) and cause uncontrolled cell growth. Researchers want to find the right dose and see if this drug can slow or shrink tumors. **You may be eligible if:** - You have advanced or metastatic solid tumor cancer (not colorectal cancer) - Your tumor has a confirmed BRAF V600 mutation - Your tumor is measurable on scans - You have had prior treatment appropriate for your cancer type - Your organ function meets the required levels **You may NOT be eligible if:** - You have colorectal cancer - You have had another active cancer within the past 3 years - You have cancer that has spread to the membranes around the brain (leptomeningeal disease) - You have a history of retinal vein blockage or certain eye conditions - You have active inflammatory lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-07799544

Tablet

DRUGPF-07799933

Tablet

Locations(77)

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

Dana-Farber Cancer Institute

Boston, 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