Active not recruitingPHASE1INTERVENTIONAL

Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

This research is looking at a new drug called GS-9911, either on its own or combined with another treatment called Zimberelimab, for adults who have advanced solid tumours. This is the very first time these drugs are being tested in people. The main aim is to understand how safe they are and to figure out the best dose to give. Researchers also want to see if the combined treatment might be helpful. This study is an important early step to see if these treatments could eventually help people with cancer. They are recruiting patients who have already tried other treatments or can't have them.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Gilead Sciences

Enrolment target

Start

09 Oct 2023

Estimated completion

01 Dec 2026

Solid Tumors

What is this study about?

This study is an early-stage clinical trial looking into a new medication called GS-9911. The main goal is to understand how safe GS-9911 is when given to adults with advanced solid tumours. It will be tested in two ways: first, on its own, and second, in combination with an existing antibody treatment called Zimberelimab. Because it's a 'first-in-human' study, the researchers will also be carefully working out the best dose of GS-9911 to use.

Solid tumours are growths made of abnormal cells that don't include blood cancers. 'Advanced' means the cancer has spread or isn't responding to standard treatments. By testing a new drug in combination with an existing one, researchers hope to see if this new approach could be more effective than current treatments, or if it could offer an option for people whose cancer hasn't responded to other medicines.

Understanding the safety and finding the right dose are crucial first steps in developing any new cancer treatment. If this early study shows promising results, it could pave the way for larger studies to further investigate if these treatments can improve outcomes for patients with solid tumours.

Key takeaways

New study for adults with advanced solid cancers.
Investigating a new drug (GS-9911), alone or with another treatment (Zimberelimab).
Main focus is safety and finding the best dose.
For those who have tried other treatments or can't have them.
Participants will have regular check-ups and follow-up.

Who may be eligible?

To join this study, you must be an adult aged 18 or older with an advanced solid tumour. This means your cancer has either spread or hasn't responded well to standard treatments. You should also have tried other available treatments, or be unable to have them. Your cancer needs to be measurable or visible to doctors so they can track any changes.

Additionally, your general health and how well your body is working (like your organs) will be checked to make sure you're well enough to take part. You'll also need to provide a tissue sample (biopsy) of your tumour before starting the treatment.

You would not be able to join if you are pregnant or breastfeeding, or if you've had a strong reaction to similar treatments in the past. There's also a waiting period after certain previous treatments, such as surgery or chemotherapy, before you can join 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 solid tumour that is advanced or has spread?
Have you tried other cancer treatments, or are you unable to have them?
Are you generally well enough to take part in a study?
Are you willing to provide a tumour tissue sample?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive either the new drug GS-9911 on its own, or GS-9911 combined with Zimberelimab. You'll have regular visits to the hospital for checks, blood tests, and scans to see how your body is responding to the treatment and to monitor for any side effects. Doctors will also take tissue samples before and sometimes during the treatment.

The study will involve carefully increasing the dose of the medication in some parts, so participants will be closely monitored. The total length of time you'll be on the study treatment will vary depending on your individual response and safety, but you will have follow-up appointments after the main treatment phase.

Potential risks and benefits

Potential benefits of taking part include access to a new drug that is not yet widely available, which might help your cancer when other treatments haven't. You would also be contributing to medical knowledge that could help future patients. However, as with any new medication, there are potential risks and side effects that are not yet fully known. The research team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Smilow Cancer Hospital Phase 1 Unit
Verified postcode
New Haven, United States
SCRI Oncology Partners
Verified postcode
Nashville, United States
NEXT Oncology
Verified postcode
San Antonio, United States
South Texas Accelerated Research Therapeutics, LLC
Verified postcode
San Antonio, United States
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
University Health Network, Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas, unlike some other types of cancer like leukaemia.

What does 'first-in-human' mean?

It means this is the very first time this new drug is being given to people, so researchers are being extra careful to check its safety and how the body reacts to it.

What is Zimberelimab?

Zimberelimab is a type of antibody treatment that helps your own immune system fight cancer cells. It's already known to be helpful for some cancers.

Why is finding the 'right dose' important?

Finding the right dose means giving enough medication to be effective against the cancer, but not so much that it causes too many serious side effects. It's a careful balance.

Will I know if I'm getting the new drug alone or with the antibody treatment?

This study is designed so some participants will get GS-9911 alone and others will get it with Zimberelimab. The research team will explain which part of the study you might join and what that involves.