Active not recruitingPHASE1INTERVENTIONAL

Study of GS-4528 in Adults With Solid Tumors

This important study is looking into a new treatment called GS-4528 for adults who have solid cancers. Researchers are testing GS-4528 by itself and also alongside another drug called Zimberelimab. The main goals are to check if these treatments are safe and if people can tolerate them well. They also want to find the best and safest dose of GS-4528 to use in the future, both on its own and when given with Zimberelimab. This type of early study helps doctors understand how new medicines work in the body before they can be used more widely, offering hope for new ways to fight cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Gilead Sciences

Enrolment target

182

Start

11 May 2023

Estimated completion

01 Jul 2026

Solid Tumor

What is this study about?

This clinical study is like an early step in finding new treatments for solid cancers. Researchers are focusing on a new drug called GS-4528. They want to see how safe it is and how well people can tolerate it. They are testing GS-4528 in two ways: first, on its own, and second, in combination with another approved cancer drug called Zimberelimab. This is important because combining treatments can sometimes be more effective than using just one.

The main purpose of this study is to find the right amount, or 'dose,' of GS-4528 that works best while still being safe. They will test different doses to make sure it's well-tolerated. Finding the right dose is key for any new medicine. This study is aimed at adults who have solid cancers.

By taking part, individuals contribute to medical knowledge and help researchers understand if GS-4528 could become a useful new treatment option in the future. This kind of research is vital for developing better ways to treat cancer and improve patients' lives, even though it's an early stage of investigation.

Key takeaways

This study is for adults with solid cancers that haven't responded to, or can't receive, other treatments.
It's testing a new drug, GS-4528, alone or with Zimberelimab, to check safety and find the best dose.
Participation involves regular clinic visits, blood tests, scans, and tissue samples.
This is an early-stage (Phase 1) study focused on understanding how the new drug works.
You can withdraw from the study at any time.
The study helps develop potential new cancer treatments for the future.

Who may be eligible?

To join this study, you would generally need to be an adult with a solid tumour that has either not responded to other treatments, or you couldn't take those treatments, or they caused too many problems. We would also need to see that your general health is good, for example, your body's organs like your liver and kidneys are working well.

You would need to have cancer that we can measure properly, usually with scans. Also, if you are a woman who could become pregnant, you would need to agree to use effective birth control during the study.

There are also reasons why someone might not be able to join. For example, if you are pregnant or breastfeeding, or if you've recently had other major cancer treatments, surgery, or radiation therapy within a certain time frame. Having certain other medical conditions or having had a transplant in the past would also prevent you from joining.

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 an adult with a solid cancer?
Has your cancer either not responded to other treatments, or are you unable to take them?
Is your general health, including your organ function, considered good?
If you are a woman able to have children, are you willing to use birth control?
Have you not had any major cancer treatments (like surgery, chemo, radiation) very recently?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure you're eligible. During the study, you would receive the new drug, GS-4528, either on its own or in combination with Zimberelimab. This would involve regular visits to the clinic for medical examinations, blood tests, and scans to monitor your health and how the treatment is affecting you and your cancer. You would also need to provide a small sample of your tumour tissue before starting the treatment.

For some participants, an additional tumour sample might be needed during the treatment to look at how the drug is working. The study team would closely monitor you for any side effects and manage them as needed. The total duration of your participation would be explained by the study team, and it would involve ongoing check-ins and follow-up appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new cancer treatment that is not yet widely available; however, it's important to remember that this is an early-stage study, and the exact benefits are not known. There are potential risks, as with any medical treatment, including side effects from the study drugs. These side effects will be carefully monitored by the medical team. You are always in control and have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (16)

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

The University of Washington/FHCC
Verified postcode
Seattle, United States
The Ottawa Hospital
Verified postcode
Ottawa, Canada
University Health Network, Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Asan Medical Center
Verified postcode
Seoul, South Korea
Severance Hospital, Yonsei University Health Systems
Verified postcode
Seoul, South Korea
Samsung Medical Center
Verified postcode
Seoul, South Korea
NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1
Verified postcode
Barcelona, Spain
Hospital Universitari Vall D'Hebron- Oncology Service
Verified postcode
Barcelona, Spain
START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I
Verified postcode
Madrid, Spain
START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I
Verified postcode
Madrid, Spain
Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos
Verified postcode
Pamplona, Spain
Taichung Veterans General Hospital
Verified postcode
Taichung, Taiwan

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that doesn't contain cysts or liquid areas, like cancers of the lung, breast, or bowel.

What does a 'Phase 1' study mean?

A Phase 1 study is the first stage of testing a new drug in people. It mainly checks if the drug is safe, if people can tolerate it, and what the best dose might be.

What is 'monotherapy'?

Monotherapy simply means that you would receive only one treatment (GS-4528) by itself, without other cancer drugs at the same time.

Will I know if I'm getting GS-4528 alone or with Zimberelimab?

The study team will explain exactly which treatment group you would be in and what drugs you would receive.

What are 'measurable disease' and 'organ function'?

Measurable disease means your cancer can be accurately sized, usually on scans. Good organ function means your body's main organs are healthy enough to take part in the study.