Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to Evaluate AB308 in Combination with AB122 in Participants with Advanced Malignancies (ARC-12)

This is an early-phase clinical trial, meaning it's one of the first times these new medicines, AB308 and AB122, are being given to people. The study is for individuals with various advanced cancers, such as multiple myeloma (a blood cancer), lymphoma, oesophageal cancer, melanoma, breast cancer, and lung cancer, among others. The main goal is to find out if this combination of drugs is safe, how much can be given, and what effects it has on the body. This kind of research is really important for developing new ways to treat cancer, by understanding if these medicines work and are well-tolerated before larger studies are done.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Arcus Biosciences Inc.

Enrolment target

Start

10 May 2024

What is this study about?

This study is about a new combination of medicines, AB308 and AB122, that doctors hope might help people with advanced cancer. When we say 'advanced cancer,' it means the cancer has grown or spread beyond where it started. This trial is looking at many different types of cancer, including blood cancers like multiple myeloma and lymphoma, as well as solid cancers that can affect parts of the body like the oesophagus, stomach, skin (melanoma), and lungs.

Because this is a 'Phase I' trial, it’s one of the very first times these specific medicines are being given to people. The main focus at this stage isn't to cure the cancer, but to carefully check if the drugs are safe to use, how the body handles them, and to figure out the right amount (dose) to give. Researchers will be watching very closely for any side effects and how the medicines behave once they are inside the body.

Understanding how new treatments work and if they are safe is a vital first step in developing new therapies. While this early study won't provide all the answers, the information gathered here could pave the way for bigger studies in the future that might eventually lead to new treatment options for people living with these cancers.

Key takeaways

This is an early-stage study testing two new drugs (AB308 and AB122) for advanced cancers.
The main aim is to check if the new drug combination is safe and how the body copes with it.
It's for adults (18+) with various types of cancer, including both blood and solid tumours.
You will have regular hospital visits for treatment, monitoring, and tests.
Potential benefits include access to new treatment; risks involve unknown side effects.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. There's no upper age limit, so people of all adult ages are welcome.

This study is for people who have one of the many types of advanced cancer listed, such as multiple myeloma, certain lymphomas, oesophageal cancer, melanoma, or advanced solid tumours. It's designed for people whose cancer has progressed despite other treatments, or for whom standard treatments are no longer working or aren't suitable.

Both men and women can take part in this research. More specific health checks will be done by the study team to make sure it's safe for you to join and that the study is right for your particular situation.

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?
Have you been diagnosed with an advanced cancer like those mentioned (e.g., myeloma, lymphoma, oesophageal cancer, melanoma, lung cancer)?
Have you discussed clinical trials with your doctor?
Are you able to attend regular appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you’ll work closely with a team of doctors and nurses. Initially, you'll have a number of appointments for health checks, blood tests, and scans to make sure you're suitable for the trial. Once you start the treatment, you’ll receive the study drugs, AB308 and AB122, according to a schedule set by the researchers. This will involve regular visits to the hospital or clinic.

During these visits, the medical team will monitor you closely. They'll perform more blood tests, physical examinations, and possibly scans to see how your body is responding to the medication and to check for any side effects. The exact number and frequency of visits, as well as the total length of time you'll be on the study drugs, will vary depending on your individual response and how well you tolerate the treatment. There will also be follow-up appointments after you finish taking the medication to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as gaining access to a new experimental treatment that isn't yet widely available. While there's a chance the treatment might help your cancer, it's important to remember that this is an early-stage study, so the main goal is to understand safety, not necessarily direct benefit. There are also potential risks; new medicines can have side effects that are not fully known yet, ranging from mild to serious. The study team will explain all known side effects and monitor you very closely. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Poland

Common questions

What does 'advanced malignancies' mean?

It means the cancer has grown or spread from where it started in the body.

Is this treatment guaranteed to cure my cancer?

No, this is an early study (Phase I) mainly looking at the safety of new drugs, not a cure.

Will I have to pay to be in the study?

No, usually all study-related treatments and tests are provided free of charge.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.

What's the difference between AB308 and AB122?

These are the names of two experimental drugs being tested together in this study. Their individual actions are part of what the researchers are studying.