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A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene.
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication. 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-07985045) as pill by mouth. This will be repeated 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-07985045 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 different times (depending on the treatment) during the 21-day or 28-day cycle. Participants can continue to take the study medication (PF-07985045) 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 in this study for up to 4 years. During this time, the participants will come into the clinic for 1 to 4 times in each 21-day or 28-day cycle. After the participants 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-07985045 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-12-10
Completion Date
2029-03-11
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
PF-07985045
KRAS 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
Sasanlimab
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)
PF-07284892
PF-07284892 used as a combination product.
Locations (13)
Highlands Oncology Group
Fayetteville, Arkansas, United States
Highlands Oncology Group
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
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
DFCI Chestnut Hill
Newton, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
The Trustees of Columbia University and The New York and Presbyterian Hospital
New York, New York, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center-University Hospital
Madison, Wisconsin, United States
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico