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A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose. This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that: * are advanced (cancer that doesn't disappear or stay away with treatment) and * have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers). This includes (but limited to) the following cancer types: Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control. Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels. All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles. Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle. Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
Official title: A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
330
Start Date
2024-06-27
Completion Date
2028-09-09
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
PF-07934040
panKRAS inhibitor
Gemcitabine
Chemotherapy (antimetabolite)
Nab-paclitaxel
Taxane-type Chemotherapy
Cetuximab
Monoclonal Antibody (EGFR Inhibitor)
Fluorouracil
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Oxaliplatin
Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
Leucovorin
Part of FOLFOX chemotherapy regimen Folic Acid Analog
Bevacizumab
VEG-F inhibitor
Pembrolizumab
immune checkpoint inhibitor (PD-1 inhibitor)
pemetrexed
Can be used in Platinum-based Chemotherapy regimen Antimetabolite
Cisplatin
Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)
Paclitaxel
Can be used in Platinum-based chemotherapy regimen Taxane
Carboplatin
Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)
Locations (28)
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
City of Hope Investigational Drug Service (IDS)
Duarte, California, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado, United States
University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
START Midwest
Grand Rapids, Michigan, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Duke University Medical Center, lnvestigational Chemotherapy Service
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
West Chester Hospital
West Chester, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico