Active not recruitingPHASE2INTERVENTIONAL

Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

This research study is looking at a new medicine called PF-07220060 for adults with advanced solid tumours, which include certain types of breast cancer, prostate cancer, lung cancer, and liposarcoma. The main goals are to check if the new drug is safe, how well people can tolerate it, and how it behaves in the body. It will be tested on its own and in combination with other existing cancer treatments like letrozole, fulvestrant, and enzalutamide. The study is split into different parts, gradually increasing the dose and then expanding to include more people, to find the best way to use this potential new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Pfizer

Enrolment target

362

Start

23 Sep 2020

Estimated completion

23 Nov 2027

Liposarcoma Prostate Cancer Breast Neoplasms Adenocarcinoma of Lung

What is this study about?

This study is about a new investigational drug, PF-07220060, which doctors hope could help people living with advanced solid tumours. "Investigational" means it's not yet approved for general use, and this research is a vital step in understanding if it's a safe and effective treatment option. The cancers being looked at in this study include specific types of breast cancer, prostate cancer, lung cancer (adenocarcinoma), and a rare soft tissue cancer called liposarcoma.

The researchers are particularly interested in how PF-07220060 works in the body, whether it causes side effects, and what dose is best. They will test it on its own first, similar to how an explorer might first chart a route before bringing in a team. Then, they'll explore how it works when given alongside other common cancer treatments like letrozole, fulvestrant, and enzalutamide. This is like trying to find the best combination of tools for a specific job.

The study has a few stages. Initially, small groups of people will receive increasing doses of PF-07220060 to find a safe and tolerable amount. Later, more people will join to further test the drug, both alone and in combinations, for specific types of cancer. This careful, step-by-step approach helps ensure that any new treatment is thoroughly understood before it can be considered for wider use.

Key takeaways

This study is testing a new drug, PF-07220060, for certain advanced cancers.
It aims to find out if the drug is safe, how it works, and at what dose.
The drug will be tested alone and with other existing cancer medicines.
Cancers included are specific types of breast, prostate, lung cancer, and liposarcoma.
Participation involves regular clinic visits, blood tests, and scans.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you generally need to be an adult, aged 18 or older, and have certain types of advanced solid tumours. These include specific forms of breast cancer (especially those that are hormone receptor-positive and HER2-negative), prostate cancer, a type of lung cancer, or liposarcoma. For some parts of the study, you'll need to have tried and not responded well to at least one previous standard cancer treatment.

Your cancer must also be measurable or evaluable, meaning doctors can see and track its size. For women with breast cancer, some parts of the study are for those who have gone through menopause, while others might include women who are still having periods. You cannot participate if you only have a biochemical recurrence (measured by blood tests) without any visible signs of the disease.

Each part of the study has slightly different requirements, so it's important to discuss your specific medical history and cancer type with the study doctors to see if you might be a good fit.

Quick self-check

Are you 18 years old or older?
Do you have advanced breast cancer (HR-positive, HER2-negative), prostate cancer, adenocarcinoma of the lung, or liposarcoma?
Have you already tried at least one other standard cancer treatment for your advanced cancer?
Can your cancer be measured or seen by doctors (is it 'evaluable' or 'measurable')?
Are you able to attend regular clinic appointments and undergo study-related tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study is a "Phase 1/2A" trial, which means it's an early-stage study designed to understand the new drug better. You would receive the study drug, PF-07220060, either by itself or along with other approved cancer medications like letrozole, fulvestrant, or enzalutamide, depending on which part of the study you join. The drug will be given multiple times.

Throughout the study, you will have regular visits to the clinic for various assessments. These will include blood tests to check how the drug is working in your body and to monitor for any side effects. You'll also undergo scans and examinations to track your cancer. For some participants, there might be specific tests, such as those looking at how food affects the drug or how it interacts with another common medication (midazolam). The total duration of your participation will depend on which part of the study you are in and how you respond to the treatment.

Potential risks and benefits

Participating in a clinical trial can offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical attention from a specialist team. However, there are also potential risks. The study drug, PF-07220060, is still experimental, meaning its full side effect profile isn't completely known. You might experience side effects that range from mild to serious. There’s also no guarantee that the treatment will be effective for your cancer. Your well-being and safety are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

Ellison Institute
Los Angeles, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, United States
Brigham & Women's Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, United States
START Midwest
Grand Rapids, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, United States
SCRI Oncology Partners
Nashville, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Argentina

+26 more sites — see the official record for the full list.

Common questions

What kind of new drug is PF-07220060?

It's an experimental drug for advanced solid tumours. Researchers are trying to understand how it works, if it's safe, and what doses are best, both alone and with other cancer medicines.

Which cancers are being studied?

The study focuses on certain advanced solid tumours, including specific types of breast cancer, prostate cancer, a type of lung cancer (adenocarcinoma), and liposarcoma.

Will I take the new drug only, or with other treatments?

Depending on which part of the study you join, you might receive PF-07220060 by itself or alongside other standard cancer treatments like letrozole, fulvestrant, or enzalutamide.

What does 'advanced solid tumours' mean?

This refers to cancers that have grown or spread beyond where they started and have formed solid masses of cells, like those in the breast, prostate, or lung.

What happens after I finish the study treatment?

The study team will continue to monitor your health and follow your progress as needed. They will provide information regarding your ongoing care with your regular doctors.