A Phase II, Single-Arm, Open-Label Study Evaluating the Safety and Pharmacokinetics of the Intravenous Fixed‑Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants with Locally Advanced, Recurrent or Metastatic Solid Tumors
This study is a Phase II clinical trial looking into a new treatment for people living with solid tumours that are advanced, have come back, or have spread. The treatment involves a combination of two drugs, tiragolumab and atezolizumab, given directly into the bloodstream (intravenously). We want to understand how safe this drug combination is and if it causes any side effects. Researchers will also be checking how the body processes these drugs. This is an early-stage study, and the main goal is to gather important information about safety and how the drugs work in the body before potentially moving to larger studies.
At a glance
What is this study about?
This study is called a 'Phase II, single-arm, open-label study,' which means it's an early-stage research project. We're looking at a new way to treat certain advanced solid tumours. Solid tumours are growths of abnormal cells in organs or tissues, like in the breast, lung, or bowel, rather than in the blood or bone marrow.
The treatment being tested is a combination of two medicines, tiragolumab and atezolizumab. These drugs are given together directly into a vein. The main goal of this study is to carefully watch for any side effects and understand how safe this combination treatment is for patients. We'll also be learning how the body handles these medicines – how they are absorbed, distributed, processed, and removed.
By understanding the safety and how the body copes with these drugs, we can decide if this treatment shows enough promise to be studied in larger groups of people in the future. This kind of research is vital for developing new and potentially better treatments for complex diseases like cancer. It's a key step in finding new ways to help patients.
Key takeaways
- This study tests a new combination of two drugs for advanced solid tumours.
- It's an early-stage (Phase II) study focusing on safety and how the body handles the drugs.
- The treatment is given directly into a vein.
- All participants will receive the active study drug combination.
- Close monitoring for side effects is a key part of the study.
- Adults aged 18 and over with certain solid tumours may be eligible.
Who may be eligible?
This study is looking for adults aged 18 or older. Both men and women can take part.
To be considered for this study, you must have a solid tumour that is locally advanced (meaning it has grown into nearby tissues), has come back after previous treatment, or has spread to other parts of the body (this is called metastatic cancer).
There will be other detailed criteria, like your general health and previous treatments, that the study doctors will check to make sure the study is a good fit for you and safe for you to participate.
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, has come back, or has spread?
- Are you able to attend regular clinic visits?
- Are you willing to receive the study drugs through an IV (drip into a vein)?
What does participation involve?
If you join this study, you will receive the experimental drug combination (tiragolumab and atezolizumab) as an infusion into a vein. This study is 'single-arm,' meaning everyone taking part will receive this specific treatment. There isn't a placebo or another standard treatment group for comparison in this phase.
You will have regular visits to the clinic for your infusions and to have various tests performed. These tests will include blood samples to check how the drugs are affecting your body, how much of the drug is in your system, and to look for any side effects. You will also have physical examinations and other health checks regularly. The study doctors and nurses will closely monitor your health throughout your participation. The total duration of your participation in the study will be explained by the study team, including how long you might receive treatment and how long you will be followed up afterwards.
Potential risks and benefits
Locations (4)
- —UnverifiedCyprus
- —UnverifiedCroatia
- —UnverifiedSpain
- —UnverifiedGreece
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. It's found in organs or tissues, unlike cancers that affect blood or bone marrow.
What does 'intravenous fixed-dose combination' mean?
It means the two study drugs, tiragolumab and atezolizumab, are given together directly into your vein (intravenous) and the amount of each drug is set and doesn't change based on your weight.
What is 'Phase II' in a clinical trial?
Phase II means it's an early-stage study, usually after initial safety checks. It aims to see if the treatment works for a specific condition and to gather more information about its safety and side effects.
Will I get a placebo in this study?
No, this is a 'single-arm' study, meaning everyone who joins will receive the active study treatment combination of tiragolumab and atezolizumab. There is no placebo group.
Can I stop participating in the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without impacting your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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