AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

C6461020 - An Interventional Open-Label Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 in combination with Different Anticancer Agents in Participants with Advanced Solid Tumors

This research study is looking into new ways to treat advanced solid tumours. It involves a new medicine called PF-08634404, given alongside other cancer medicines. The main goals are to understand how safe this combination treatment is and what side effects it might cause. Researchers will also be checking if the treatment shrinks tumours or stops them from growing. This is an early-stage study, meaning it's one of the first times these treatments are being tested together in people. It will help doctors learn more about this potential new approach to fighting cancer.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

09 Apr 2026

Advanced Solid Tumors

What is this study about?

This research study, known as C6461020, is exploring a new treatment approach for people who have advanced solid tumours. Solid tumours are growths formed by abnormal cells, and 'advanced' means the cancer has spread or is difficult to treat with standard methods. The study will look at a new medicine called PF-08634404, which will be given together with other existing cancer treatments, including one called Sigvotatug vedotin. The study is divided into two main parts. The first part is focused on safety, helping doctors find the right dose and understand any immediate side effects.

The second part of the study will build on the safety information to see how well the treatment works. This involves checking if the tumours shrink or stop growing, and how long people respond to the treatment. Because this is an early-stage study (called Phase 1b/2), it means the treatments are still quite new and haven't been widely used yet. The information gathered will be really important for understanding if this combination of medicines could be a helpful new option for people with advanced solid tumours in the future. The study aims to gather important information without making any medical recommendations, helping to advance our understanding of potential new therapies.

The researchers will be carefully monitoring participants throughout the study. They will track any side effects, big or small, to understand the safety profile of the new combination. They will also take blood samples to see how the medicines are absorbed and processed by the body. Another key aspect is measuring how the tumours react to the treatment. This will help them determine if the treatment has a positive effect on the cancer. All findings will help doctors better understand how patients react to the new medication and whether further studies would be beneficial.

Key takeaways

It's a study for advanced solid tumours.
Testing a new combination of medicines, including PF-08634404.
Main goals are checking safety and potential tumour response.
Early-stage research, so treatments are still new.
Participants will be closely monitored for side effects and tumour changes.
This study hopes to find improved treatments for the future.

Who may be eligible?

To join this study, you need to be an adult, 18 years of age or older. Both men and women can take part. You must have advanced solid tumours.

There will be other detailed criteria that medical staff will check to make sure the study is a good and safe fit for you. These criteria often include things like your overall health, other medical conditions you might have, and previous treatments you've received. They are in place to ensure your safety and the quality of the study results.

Your doctor will be able to tell you if your specific situation meets all the requirements to be considered for this study.

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 a diagnosis of advanced solid tumours?
Are you able to attend regular hospital or clinic visits?
Are you willing to undergo various medical tests, like blood tests and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine PF-08634404, combined with other cancer treatments. The study involves regular visits to the hospital or clinic. During these visits, you will have various checks, such as blood tests, physical examinations, and scans (like CT or MRI). These tests help doctors monitor your health, check for any side effects, and see how the treatment is affecting your tumour.

Initially, the study will focus on finding the safest dose of the new medicine. Once a safe dose is found, more people will join to see how well it works. The medical team will explain the full schedule of visits, tests, and how long you might be on the treatment. You will be closely monitored throughout your participation, and the total duration would depend on individual response to treatment, but the team will be able to give you an estimate.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that isn't widely available yet, which could help your advanced solid tumours. However, as with any new medicine, there are potential risks, including side effects that we don't fully know about yet. These side effects could range from mild to serious. The research team will explain all known side effects and monitor you very closely for any new ones. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
France
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Unverified
Germany

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumours, which are growths made of abnormal cells that have spread or are difficult to treat.

What medicines are being tested?

The study is testing a new medicine called PF-08634404 in combination with other anti-cancer agents, including one called Sigvotatug vedotin.

Why is this study important?

It's an early-stage study that aims to find out if this new combination treatment is safe and effective for advanced solid tumours, potentially leading to new treatment options in the future.

Will I get the new treatment if I join?

Yes, if you meet the study criteria, you will receive the new medicine PF-08634404 along with other specified cancer medicines.

Who can join this study?

Adults aged 18 or over with advanced solid tumours are invited to apply. There will be other specific health requirements that your doctor can discuss with you.