190 Participants Needed

PF-07985045 for Cancer

Recruiting at 15 trial locations
PC
Overseen ByPfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer treatment called PF-07985045, an experimental treatment, to assess its safety and effectiveness. It focuses on patients with advanced solid tumors that have a KRAS gene mutation, which can lead to rapid cell growth, particularly in lung, colorectal, or pancreatic cancer. The trial tests the medication alone and in combination with other cancer treatments. Ideal candidates are those whose cancer has not responded to current treatments and have a KRAS mutation. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot use proton pump inhibitors (PPIs) within seven days before starting the study treatment. It's best to discuss your current medications with the trial team to get specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers tested PF-07985045 alone and with other cancer treatments to assess its safety in humans. As a standalone treatment, the safety and effects of PF-07985045 remain under investigation, so information on its side effects is limited. Some combinations have been tested before. For example, using FOLFOX and cetuximab together can cause rashes, but these are usually manageable. Similarly, combining bevacizumab with FOLFOX has proven effective, though it may increase side effects like bleeding and high blood pressure.

For other combinations, such as PF-07985045 with PF-07284892, more data is needed because the safety is not fully known. The same applies to the combination with pembrolizumab (pembro) and sasanlimab, which are also still being explored for safety in humans.

Since this trial is in Phase 1, the main goal is to determine how well people tolerate PF-07985045 and its combinations. Researchers are just beginning to assess its safety. In this early phase, the safety of the treatment is not yet fully understood. Participants will be monitored closely for any side effects during the trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07985045 because it offers a fresh approach to cancer treatment by combining with existing chemotherapy and targeted therapies. Unlike standard treatments like FOLFOX or Cetuximab, PF-07985045 works uniquely by possibly enhancing the effects of these drugs, potentially improving outcomes in cancers like colorectal and non-small cell lung cancer. Moreover, its ability to be used in combination with multiple agents, such as Pembro, sasanlimab, and Bevacizumab, highlights its versatility and potential to address a variety of cancer types more effectively. This multi-targeted strategy may offer new hope for patients, aiming to tackle cancer cells more efficiently and possibly reducing side effects compared to conventional approaches.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that PF-07985045 is a promising new treatment for cancers with a common gene mutation called KRAS. This medication blocks signals that help cancer cells grow. The trial studies PF-07985045 in various treatment arms. For instance, one arm combines PF-07985045 with drugs like FOLFOX and cetuximab, which has helped shrink colorectal tumors. Another arm explores the combination of PF-07985045 with pembrolizumab and chemotherapy, showing improved results for non-small-cell lung cancer. Although still in early stages, these findings suggest that PF-07985045 could be effective against cancers with KRAS mutations.14678

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors like lung, colorectal, or pancreatic cancer that have grown despite treatment and have a specific DNA change in the KRAS gene. Participants should be relatively healthy (ECOG PS 0 or 1), have at least one measurable tumor not treated by radiation before, and must not have been effectively treated by certain targeted therapies if they carry specific mutations.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.
My pancreatic cancer is adenocarcinoma and has spread beyond the pancreas.
My NSCLC has a mutation and did not respond well to targeted therapy.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07985045 alone or in combination with other anti-cancer therapies in 21-day or 28-day cycles

Up to 2 years
1 to 4 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • PF-07985045
Trial Overview The study tests PF-07985045 alone or with other anti-cancer drugs (like Paclitaxel, Carboplatin) to find the safest and most effective dose. It's given orally daily in cycles of 21 or 28 days. Other drugs may be administered intravenously during these cycles until there's no response from the cancer.
How Is the Trial Designed?
12Treatment groups
Experimental Treatment
Group I: Part 2 Cohort XExperimental Treatment2 Interventions
Group II: Part 2 Cohort C3Experimental Treatment6 Interventions
Group III: Part 2 Cohort C2Experimental Treatment3 Interventions
Group IV: Part 2 Cohort B4Experimental Treatment5 Interventions
Group V: Part 2 Cohort B3Experimental Treatment5 Interventions
Group VI: Part 2 Cohort B2Experimental Treatment2 Interventions
Group VII: Part 2 Cohort A2Experimental Treatment3 Interventions
Group VIII: Part 1 Dose EscalationExperimental Treatment1 Intervention
Group IX: Part 1 Cohort D1Experimental Treatment1 Intervention
Group X: Part 1 Cohort C1Experimental Treatment1 Intervention
Group XI: Part 1 Cohort B1Experimental Treatment1 Intervention
Group XII: Part 1 Cohort A1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
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Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

NCT06704724 | A Study to Learn About the ...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.
Efficacy of cetuximab-based chemotherapy in metastatic ...The meta-analysis demonstrated that cetuximab-based chemotherapeutic regimens led to a marked improvement in OS in patients with mCRC who lacked any RAS ...
PF-07985045 for CancerThe 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.
Trial: A Study to Learn About the Study Medici… - HealthScoutPF-07985045 (PF-5045) is an investigational, oral KRAS pathway inhibitor under early clinical development; it aims to inhibit oncogenic KRAS signaling with ...
Q2 2025 Pipeline Update_vFinal3.pdfMedian OS was 30.3 months with BRAFTOVI in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without ...
A Study to Learn About the Study Medicine PF-07985045 ...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.
KRAS InhibitorKRAS Inhibitor. PF-07985045 is an investigational compound. Its safety and efficacy have not been established. A PHASE 1 OPEN-LABEL STUDY OF PF-07985045 AS ...
Targeting the KRAS Oncogene for Patients with Metastatic ...Efficacy and Safety of Adagrasib plus Cetuximab in Patients with KRASG12C-Mutated Metastatic Colorectal Cancer. Cancer Discov. 2024;14:982 ...
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