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NCT05538130PHASE1Recruiting

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

Pfizer

Start Date

11/30/2022

Completion Date

6/18/2029

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 Criteria

Age Range: 16 years to No maximum

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

Interventions

DRUG

PF-07799544

DRUG

PF-07799933

Interested in This Trial?

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Conditions

MelanomaGliomaThyroid CancerNon-Small Cell Lung CancerMalignant NeoplasmsBrain NeoplasmsAdvanced or Metastatic Solid TumorsHGGLGGLow Grade GliomaHigh Grade GliomaDifferentiated Thyroid CancerNSCLC (Non-small Cell Lung Cancer)

Locations

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

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Ophthalmic Consultants of Boston Inc (OCB)

Boston, Massachusetts 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mass General Waltham

Waltham, Massachusetts 02451

United States

Brigitte Harris Cancer Pavilion

Detroit, Michigan 48202

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota 55426

United States

Methodist Hospital Inpatient Pharmacy

Saint Louis Park, Minnesota 55426

United States

HealthPartners Cancer Center at regions Hospital

Saint Paul, Minnesota 55101

United States

Regions Hospital Pharmacy

Saint Paul, Minnesota 55101

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

Optum Medical Care, PC

Brewster, New York 10509

United States

MSK Commack.

Commack, New York 11725

United States

MSK Westchester.

Harrison, New York 10604

United States

Optum Medical Care, PC

Mount Kisco, New York 10549

United States

Laura & Isaac Perlmutter Cancer Center - NYU ACC

New York, New York 10016

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York 10016

United States

NYU Langone Faculty Group Practice

New York, New York 10016

United States

NYU Langone Medical Center (Tisch Hospital)

New York, New York 10016

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

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

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

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul 91350-200

Brazil

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

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

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

Sourasky Medical Center

Tel Aviv, TELL ABĪB 6423906

Israel

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan