Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

C6081001: A Phase 1 Study of PF-07985045 in Participants with Advanced Solid Tumors

This research study is looking for people aged 18 or older who have advanced cancer where the cancer cells have a particular fault in their genes, known as a 'KRAS mutation'. The study is called C6081001 and it's a very early-stage trial (Phase 1). This means it's the first time the new study medicine, PF-07985045, is being given to people. The main goal is to find out if the medicine is safe, what dose can be given, and how it behaves in the body, rather than focusing on treating the cancer at this stage. Both men and women can take part. It's a way to learn more about this potential new medicine.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Pfizer Inc.

Enrolment target

Start

19 Jun 2025

KRAS mutated advanced solid tumors

What is this study about?

This study, called C6081001, is a very early stage of research, often called 'Phase 1'. It's designed to be the first time a new medicine, named PF-07985045, is given to people. The main purpose of this initial step is not to cure cancer, but to carefully check if the medicine is safe for people, how much can be given without causing serious problems, and how it moves through and is used by the body. This information is absolutely vital before the medicine can be tested in larger groups of people.

The study is specifically looking for people who have advanced solid tumours – this means cancers that started in organs like the lung, colon, or breast, and have grown or spread. A key part of qualifying for this study is that your cancer cells must have a specific genetic change called a 'KRAS mutation'. Scientists believe this mutation could be a weakness in the cancer that this new medicine might be able to target.

By taking part, you would be contributing to scientific knowledge that could help develop new treatments for future cancer patients. While there's no guarantee of personal benefit, early studies like this are crucial steps in finding new ways to fight cancer.

Key takeaways

This is a very early-stage (Phase 1) study for a new cancer medicine.
It's for people with advanced solid tumours that have a specific 'KRAS mutation'.
The main goal is to test the medicine's safety and how it works in the body.
Participants must be 18 years old or over, and can be male or female.
You won't necessarily benefit directly, but you'll help advance cancer research.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit. Both men and women can take part.

A crucial requirement is that your advanced solid tumour must have a specific genetic change known as a 'KRAS mutation'. This means your doctors will need to have tested your cancer cells and found this particular change. If your cancer doesn't have this mutation, you wouldn't be able to join this specific study. Your medical team will also check other health factors to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an advanced solid tumour (cancer that has grown or spread)?
Has your doctor told you that your cancer has a 'KRAS mutation'?
Are you able to attend regular hospital or clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the new medicine, PF-07985045. Because this is a very early stage study, there would be regular visits to the hospital or clinic. These visits are important for the study doctors and nurses to closely monitor your health, check for any side effects, and see how your body is reacting to the medicine.

During these visits, you would likely have blood tests, scans, and other medical examinations. The study team will explain the full schedule of visits and assessments before you agree to take part. The total duration of your participation would depend on how your body responds to the medicine and what the study doctors decide is best for your safety. There would also be follow-up appointments after you stop taking the study medicine to make sure you are well.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from this study, as the main goal is to understand the new medicine's safety, not to treat your cancer at this stage. However, you would be playing a vital role in advancing medical science, which could help others in the future. Potential risks are unknown with a new medicine, but the study team will closely monitor you for any side effects, and they will fully explain all known and possible side effects before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain

Common questions

What is a 'Phase 1' study?

It's the very first time a new medicine is given to people. The main aim is to check if it's safe, how much can be given, and what it does in the body. It’s not primarily about treating your cancer.

What does 'KRAS mutated advanced solid tumours' mean?

This means you have cancer that started in an organ (a 'solid tumour') and has grown or spread ('advanced'). Also, your cancer cells have a specific genetic change called a 'KRAS mutation'.

Will this medicine cure my cancer?

It's highly unlikely at this early stage. The study is focused on safety and understanding the drug, rather than treating the cancer. Any positive effect on your cancer would be a bonus, but not the primary goal.

How long would I be in the study?

The exact duration can vary. The study team will explain the expected total time involved, including regular check-ups and follow-up after stopping the medicine.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason. Your decision will not affect your regular medical care or relationship with your doctors.