RecruitingPHASE1INTERVENTIONAL

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

This study is looking into a new drug called PF-08046050 for adults with advanced solid tumours. Solid tumours are cancers that start as a growth in an organ like the lung or bowel, rather than in the blood. For this study, the cancers must be difficult to treat, have come back after treatment, or have spread to other parts of the body. The new drug, PF-08046050, is designed to target and kill cancer cells. Researchers want to find out the safest dose and if it can help improve these hard-to-treat cancers. This study involves several parts, some looking at the new drug on its own, and others testing it alongside existing anti-cancer medicines.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

914

Start

20 Nov 2023

Estimated completion

12 Sep 2030

Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Pancreatic Ductal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Small Cell Lung Carcinoma

What is this study about?

This study is about a new way to treat certain advanced cancers. These are cancers that have grown quite large in one area, have come back, or have spread to other parts of the body (called metastatic cancer). For people in this study, their cancer hasn't responded well to usual treatments, or those treatments aren't suitable anymore. The study focuses on cancers like those in the bowel, lung, stomach, or pancreas.

The main aim is to test a new experimental drug called PF-08046050. This drug is a special type of medicine that includes an antibody – like a homing missile – attached to a cancer-fighting drug. The idea is that the antibody will find and stick to cancer cells, delivering the drug directly to them to kill them, while trying to spare healthy cells. Researchers need to make sure this new medicine is safe and to find the best dose to give people.

This study has several parts. In the first parts, researchers will carefully increase the dose of PF-08046050 to find the safest amount that can be given. Later parts will then use this information to see if the drug actually helps to treat certain cancers, both on its own and when combined with other well-known cancer treatments that patients might already be taking.

Key takeaways

This study is testing a new drug for advanced, hard-to-treat solid cancers.
The new drug, PF-08046050, is designed to specifically target and kill cancer cells.
It's a Phase 1 study, focusing on finding the safest dose and looking for early signs of effectiveness.
The study includes various solid tumours like bowel, lung, stomach, and pancreatic cancer.
You might receive the new drug alone or with other standard cancer medicines.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

You might be able to join this study if you are an adult, at least 18 years old, and have a solid tumour cancer that has spread or can't be removed with surgery. Your cancer should also be one that hasn’t gotten better with previous treatments, has come back, or for which there are no standard treatments left.

Specifically, depending on the part of the study, this could include certain types of bowel, stomach, lung (non-small cell and small cell), or pancreatic cancer. You must generally have received some prior chemotherapy for your cancer, and for some lung cancers, specific targeted therapies if your cancer had certain genetic changes.

It's important to note that the study is looking for people whose cancer is advanced and has been difficult to treat using usual methods. The research team will check all your medical details to see if you meet all the requirements for taking part.

Quick self-check

Are you an adult aged 18 or over?
Do you have a solid tumour cancer (e.g., bowel, lung, stomach, pancreas) that has spread or can't be removed?
Has your cancer come back, progressed, or not responded to standard treatments?
Do you have no other suitable routine treatment options currently available?
Have you received certain past cancer treatments for your type of cancer?

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

What does participation involve?

If you join this study, the specific details of what you'll need to do might depend on which part of the study you are in. However, generally, it will involve regular hospital visits for check-ups, receiving the study medicine (PF-08046050, sometimes with other anti-cancer drugs), and having various tests done. These tests might include blood tests, scans (like CT or MRI scans) to see how the cancer is responding, and possibly other investigations to monitor your health.

You will be closely monitored for any side effects from the experimental drug. The study team will provide the medication and careful instructions on how to take it or when you will receive it. After you finish receiving the study medicine, there will be follow-up visits to continue tracking your health and progress. The total length of your participation will depend on how you respond to the treatment and the specific part of the study, but all details will be explained before you agree to take part.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new, experimental drug that might help treat your cancer, especially if standard treatments haven't worked or are no longer suitable. However, this drug is still being tested, so there's no guarantee it will be effective for you, and it may not be better than existing treatments. Like all medicines, especially cancer treatments, there's a risk of side effects, which could be serious. The study team will carefully monitor you for these and explain all known risks. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (44)

Mayo Clinic Hospital
Phoenix, United States· Recruiting
Mayo Clinic
Scottsdale, United States· Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, United States· Recruiting
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, United States· Recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, United States· Recruiting
University of Colorado Hospital
Aurora, United States· Recruiting
Florida Cancer Specialists
Orlando, United States· Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, United States· Recruiting
Sidney Kimmel Comprehensive Cancer at Johns Hopkins
Baltimore, United States· Recruiting
The Johns Hopkins University
Baltimore, United States· Recruiting
Beth Israel Deaconess Medical Center
Boston, United States· Recruiting
Beth Israel Deaconess Medical Center
Boston, United States· Recruiting

+32 more sites — see the official record for the full list.

Common questions

What is a 'solid tumour'?

A solid tumour is a growth of abnormal cells that forms a lump in an organ, like in your lung, stomach, or bowel, rather than a cancer of the blood.

What does 'experimental drug' mean?

An experimental drug means it’s a new medicine that doctors are testing. It hasn't been approved for general use yet because more research is needed to prove it's safe and effective.

What is PF-08046050?

PF-08046050 is a new medicine being tested. It's designed to find and attach to cancer cells, then deliver a powerful drug to kill them, like a targeted therapy.

Will I definitely get the new drug?

If you join, you will receive the new drug. This study is testing the new drug directly, sometimes on its own and sometimes with other standard cancer medicines.

What happens if I receive a combination of drugs?

In some parts of the study, you might receive the experimental drug alongside other standard cancer treatments, like chemotherapy, to see if they work better together.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.