Trials / Recruiting
RecruitingNCT06447662
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2024-06-27
- Primary completion
- 2027-09-10
- Completion
- 2028-09-09
- First posted
- 2024-06-07
- Last updated
- 2026-02-25
Locations
28 sites across 3 countries: United States, China, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06447662. Inclusion in this directory is not an endorsement.