Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06447662

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.

Led by Pfizer · Updated on 2026-04-20

330

Participants Needed

28

Research Sites

238 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of advanced, unresectable, metastatic, or relapsed/refractory solid tumor confirmed by tissue or cell analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least one measurable tumor lesion not previously treated with radiation
  • Confirmed KRAS gene mutation (any variant for pancreatic, colorectal, and other tumors; all except treated G12C for non-small cell lung cancer)
  • Progression on standard treatments with no effective therapies available for parts 1 and 2a
  • Specific prior treatment requirements for pancreatic, colorectal, and non-small cell lung cancer depending on study part and line of therapy
  • No prior chemotherapy for metastatic disease for certain first-line cohorts
  • For non-small cell lung cancer first-line cohorts, must meet tumor proportion score criteria and have no prior systemic treatment
Not Eligible

You will not qualify if you...

  • Active or past lung inflammation or fibrosis needing steroid treatment
  • Immunodeficiency or active autoimmune disease needing chronic systemic steroids or immunosuppressive therapy in past 2 years
  • Sensory peripheral neuropathy grade 2 or higher
  • Active or significant gastrointestinal diseases or bleeding
  • Major surgery or radiation therapy within 4 weeks before enrollment
  • Known allergy or contraindication to study drugs or components
  • Blood, kidney, or liver abnormalities that may affect safety or treatment
  • Active bleeding disorders within past 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

2

Highlands Oncology Group, PA

Rogers, Arkansas, United States, 72758

Actively Recruiting

3

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

Actively Recruiting

4

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States, 91010

Actively Recruiting

5

City of Hope Investigational Drug Service (IDS)

Duarte, California, United States, 91010

Actively Recruiting

6

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States, 80045

Actively Recruiting

7

University of Colorado Hospital - Anschutz Outpatient Pavilion

Aurora, Colorado, United States, 80045

Actively Recruiting

8

University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

Actively Recruiting

9

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

10

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

11

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

12

Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, United States, 63376

Actively Recruiting

13

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States, 63141

Actively Recruiting

14

Siteman Cancer Center - North County

Florissant, Missouri, United States, 63031

Actively Recruiting

15

Siteman Cancer Center

St Louis, Missouri, United States, 63108

Actively Recruiting

16

Barnes-Jewish Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

17

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

18

Siteman Cancer Center - South County

St Louis, Missouri, United States, 63129

Actively Recruiting

19

Duke University Medical Center, lnvestigational Chemotherapy Service

Durham, North Carolina, United States, 27710

Actively Recruiting

20

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

21

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

22

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

Actively Recruiting

23

West Chester Hospital

West Chester, Ohio, United States, 45069

Actively Recruiting

24

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

25

Miriam Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

26

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

27

Beijing Cancer hospital

Beijing, Beijing Municipality, China, 100142

Not Yet Recruiting

28

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico, 00935

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

11

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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. | DecenTrialz