RecruitingPhase 1NCT06447662

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.

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


Sponsor

Pfizer

Enrollment

330 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study of a new experimental drug called PF-07934040, given alone or alongside other cancer treatments, for people with advanced solid tumors that have a KRAS gene mutation. KRAS mutations are found in several cancers including pancreatic, colon, and lung cancer. **You may be eligible if...** - You have an advanced, unresectable, or metastatic solid tumor confirmed by biopsy - Your tumor has a confirmed KRAS gene mutation - You have good overall function (ECOG performance status 0 or 1) - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have NSCLC with a previously treated KRAS G12C mutation - You have not received prior standard therapies appropriate for your cancer type 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-07934040

panKRAS inhibitor

COMBINATION_PRODUCTGemcitabine

Chemotherapy (antimetabolite)

COMBINATION_PRODUCTNab-paclitaxel

Taxane-type Chemotherapy

COMBINATION_PRODUCTCetuximab

Monoclonal Antibody (EGFR Inhibitor)

COMBINATION_PRODUCTFluorouracil

Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

COMBINATION_PRODUCTOxaliplatin

Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)

COMBINATION_PRODUCTLeucovorin

Part of FOLFOX chemotherapy regimen Folic Acid Analog

COMBINATION_PRODUCTBevacizumab

VEG-F inhibitor

COMBINATION_PRODUCTPembrolizumab

immune checkpoint inhibitor (PD-1 inhibitor)

COMBINATION_PRODUCTpemetrexed

Can be used in Platinum-based Chemotherapy regimen Antimetabolite

COMBINATION_PRODUCTCisplatin

Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)

COMBINATION_PRODUCTPaclitaxel

Can be used in Platinum-based chemotherapy regimen Taxane

COMBINATION_PRODUCTCarboplatin

Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)

COMBINATION_PRODUCTSasanlimab

immune checkpoint inhibitor (PD-1 inhibitor)


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

View Full Details on ClinicalTrials.gov

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NCT06447662


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