RecruitingPHASE1INTERVENTIONAL

A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

This early-stage clinical trial is investigating a new medication, PF-08046054/SGN-PDL1V, for people with advanced, solid cancers that can't be removed by surgery or have spread. The study aims to understand the safety of this new drug, both on its own and when given alongside an approved cancer medicine called pembrolizumab. Researchers will also be looking at any side effects and if the treatment shows signs of helping to control the cancer. This is a "Phase 1" study, meaning the main goal is to find a safe dose and understand how the drug behaves in the body before testing it more widely.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

714

Start

25 Oct 2022

Estimated completion

04 Jan 2029

Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma of the Head and Neck Esophageal Squamous Cell Carcinoma Triple Negative Breast Neoplasms Gastric Cancer Endometrial Cancer Pancreatic Adenocarcinoma Hepatocellular Carcinoma

What is this study about?

This clinical trial is looking at a new potential cancer drug called PF-08046054/SGN-PDL1V. It's designed for people who have solid tumours, which are cancers that form a lump, such as lung, breast, head and neck, or stomach cancers. These cancers would either be difficult to remove surgically or have spread to other parts of the body.

The study has a few different stages. Initially, researchers will give the new drug on its own to find the safest and most suitable dose. Then, they will see if this drug, at the chosen dose, helps to shrink or control the cancer. Later parts of the study will involve giving the new drug together with an existing cancer treatment called pembrolizumab, to see how safe this combination is and if together they can improve treatment outcomes.

Because this is an early-stage (Phase 1) trial, the main focus is on safety. Scientists want to understand if the drug causes any unwanted side effects and how the body handles it. While they hope to see positive effects on the cancer, the primary goal at this stage is to establish a safe dose for future, larger studies.

Key takeaways

It's an early-stage (Phase 1) trial for a new cancer drug.
Aims to find a safe dose and understand side effects.
Involves various advanced solid cancers like lung or breast cancer.
Some participants will also receive an existing drug, pembrolizumab.
Participation includes regular clinic visits and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to have certain types of solid cancer that have either spread or cannot be treated with surgery. These include specific types of lung cancer, head and neck cancer, oesophageal cancer, triple negative breast cancer, stomach cancer, womb cancer, pancreatic cancer, or liver cancer. For many parts of the study, you would have already tried other standard treatments, and either they didn't work for you, or you couldn't tolerate them, or there are no other suitable treatments available for your specific situation.

Importantly, your cancer cells would need to show a particular marker called PD-L1 (which stands for Programmed Death-Ligand 1). This is measured through past tests on your cancer tissue. You would also need to be in reasonably good general health, and your doctors would need to be able to measure the size of your cancer.

There are also some reasons why you might not be able to join, though these are not fully detailed here. The study team would discuss all inclusion and exclusion criteria with you to determine if this trial is a suitable option.

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.

Do you have an advanced solid cancer that has spread or can't be surgically removed?
Have you already had standard treatments for your cancer, or are they not suitable for you?
Do you have a specific type of cancer from the list (e.g., non-small cell lung, head and neck, triple negative breast)?
Have your cancer cells been tested and shown to have the PD-L1 marker?
Are you generally in good health and able to move around independently (ECOG performance status 0 or 1)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the specific details would depend on which part of the study you join. You would regularly visit the clinic for assessments, which might include blood tests, scans, and physical examinations. You would be given the study drug, PF-08046054/SGN-PDL1V, either on its own or in combination with pembrolizumab, according to the study schedule. The total duration of your participation would be fully explained by the study team. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which might help control your cancer. However, as this is an early-stage study, the new drug's effects on cancer are not yet fully known, and there's no guarantee it will help you personally. There are also risks involved — the new drug, and the combination with pembrolizumab, may cause side effects, some of which could be serious or unexpected. The research team will monitor you closely and explain all known and potential risks in detail. Remember, you can choose to leave the study at any time.

Locations (61)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
University of Alabama at Birmingham, IDS Pharmacy
Verified postcode
Birmingham, United States· Recruiting
University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Verified postcode
Irvine, United States· Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Verified postcode
Orange, United States· Recruiting
University of California Davis Comprehensive Cancer Center
Verified postcode
Sacramento, United States· Recruiting
University of California, Davis Medical Center
Verified postcode
Sacramento, United States· Recruiting
University of Iowa
Verified postcode
Iowa City, United States· Recruiting
Karmanos Cancer Institute
Verified postcode
Detroit, United States· Recruiting
Karmanos Cancer Institute
Verified postcode
Farmington Hills, United States· Recruiting
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States· Recruiting

Common questions

What kind of cancers is this study for?

This study is for people with advanced solid cancers like specific lung, head and neck, oesophageal, triple negative breast, stomach, womb, pancreatic, or liver cancers.

What is a 'solid tumour'?

A solid tumour is a cancer that forms a mass or lump, unlike blood cancers like leukaemia.

What does 'Phase 1' mean for a clinical trial?

Phase 1 means this is a very early stage of research, mainly focused on finding a safe dose of the new drug and checking for side effects.

Can I get this new drug if I haven't tried other treatments?

Generally, participants in this study would have already tried other standard treatments, or these treatments weren't suitable for them.

What is PD-L1 expression?

PD-L1 is a marker found on some cancer cells, which helps doctors determine if certain types of immunotherapy might be effective. For this study, your cancer would need to show this marker based on previous tests.

How to find out more

Seagen 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.