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.

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.

Conditions

• Carcinoma, Pancreatic Ductal
• Colorectal Neoplasms
• Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

PF-07934040

panKRAS inhibitor

COMBINATION_PRODUCT

Gemcitabine

Chemotherapy (antimetabolite)

COMBINATION_PRODUCT

Nab-paclitaxel

Taxane-type Chemotherapy

COMBINATION_PRODUCT

Cetuximab

Monoclonal Antibody (EGFR Inhibitor)

COMBINATION_PRODUCT

Fluorouracil

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

COMBINATION_PRODUCT

Oxaliplatin

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

COMBINATION_PRODUCT

Leucovorin

Part of FOLFOX chemotherapy regimen Folic Acid Analog

COMBINATION_PRODUCT

Bevacizumab

VEG-F inhibitor

COMBINATION_PRODUCT

Pembrolizumab

immune checkpoint inhibitor (PD-1 inhibitor)

COMBINATION_PRODUCT

pemetrexed

Can be used in Platinum-based Chemotherapy regimen Antimetabolite

COMBINATION_PRODUCT

Cisplatin

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

COMBINATION_PRODUCT

Paclitaxel

Can be used in Platinum-based chemotherapy regimen Taxane

COMBINATION_PRODUCT

Carboplatin

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

COMBINATION_PRODUCT

Sasanlimab

immune checkpoint inhibitor (PD-1 inhibitor)

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-27

Primary Completion

2028-01-19

Completion

2029-01-18

FDA Drug

Yes

Countries

• United States
• China
• Puerto Rico

Study Locations