Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple Negative Breast Cancer

The GLORIA study is a clinical trial investigating a new vaccine treatment called Adagloxad Simolenin for patients with a specific type of triple-negative breast cancer (TNBC) that tests positive for something called Globo H. This study is for people who have already had their first treatments for early-stage, high-risk TNBC. The main aim is to see if adding this vaccine can stop the cancer from coming back. Researchers will also look at how long people live, their quality of life, and any side effects. Standard treatments like Pembrolizumab and Capecitabine are also part of the study, comparing different approaches to see which is most effective in preventing recurrence.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Obi Pharma Inc.

Enrolment target

Start

09 Aug 2024

Triple Negative Breast Cancer

What is this study about?

The GLORIA study is a research project designed to explore a new way to treat triple-negative breast cancer (TNBC). This particular type of breast cancer can be more aggressive and has fewer targeted treatments compared to other breast cancers. Researchers are focusing on patients whose TNBC cells have a specific marker called Globo H. The study is investigating a new vaccine called Adagloxad Simolenin, which aims to help the body's immune system fight off any remaining cancer cells.

This study is for people who have already received their main treatments for early-stage, high-risk TNBC. It's considered an "adjuvant" treatment, meaning it's given after initial treatments like surgery or chemotherapy, to further reduce the risk of the cancer returning. The hope is that this new vaccine, possibly alongside other established medications like Pembrolizumab or Capecitabine, could offer a better chance of keeping the cancer away for longer.

Ultimately, the goal of the GLORIA study is to find out if this new vaccine can improve how long patients remain free from invasive cancer, improve their overall survival, and enhance their quality of life, without causing too many side effects. This research is important because it could lead to new and more effective treatment options for people with this challenging type of breast cancer.

Key takeaways

The GLORIA study is testing a new vaccine for a specific type of triple-negative breast cancer.
It's for people who have already had initial treatments and whose cancer has a marker called Globo H.
The main goal is to see if the vaccine can stop the cancer from returning.
The study also looks at how long people live and their quality of life.
You would receive either the new vaccine or established cancer medications.
Participation involves regular clinic visits, tests, and follow-up over several years.

Who may be eligible?

To be able to take part in the GLORIA study, you'd generally need to be an adult, aged 18 or older. The study is open to both men and women, as breast cancer can affect anyone, though it's much more common in women.

Crucially, you would need to have been diagnosed with triple-negative breast cancer (TNBC) that is considered "high-risk" and in its early stages. This means the cancer hasn't spread widely yet. Also, your cancer cells must have a specific marker called Globo H – this is a key part of who the vaccine is designed to help. You would also have already received initial treatments for your breast cancer.

There might be other specific health requirements or conditions that would determine if you can join, which a doctor or the research team would discuss with you in detail. These are put in place to ensure the study is safe and that the results are clear.

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 early-stage, high-risk triple-negative breast cancer?
Do your cancer cells have the Globo H marker?
Have you already completed your main treatments for breast cancer (like surgery/chemo)?

Answer every question to see your result.

What does participation involve?

Taking part in the GLORIA study would involve several visits to a clinic over time. These visits would include regular check-ups, where doctors would assess your health, ask about any symptoms, and perform physical examinations. You would also have blood tests and other scans or tests to monitor your health and the progress of the treatment.

The medications in the study, including the Adagloxad Simolenin vaccine, would be given according to the specific plan for your group. You might receive the vaccine, or other approved medications like Pembrolizumab or Capecitabine, or a combination. The duration of active treatment would vary depending on your assigned group, but generally, studies like this involve regular treatment over several months.

After the main treatment period, there would be a follow-up phase. During this time, you would continue to have regular check-ups, though perhaps less frequently, to see how you are doing in the long term. The total duration of your involvement, from starting treatment to the final follow-up, could be several years.

Potential risks and benefits

Like all medical treatments and studies, there are potential benefits and risks to consider if you participate in the GLORIA study. A potential benefit is that you might be among the first to receive a new treatment that could be more effective in preventing your breast cancer from returning, potentially improving your long-term health. However, there's no guarantee that the new treatment will work for everyone, as this is still being researched. Potential risks could include side effects from the study medications, which might be similar to or different from those of standard cancer treatments. These could range from mild, like fatigue or discomfort at the injection site, to more serious reactions. The research team will carefully monitor you for any side effects. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Poland

Common questions

What is triple-negative breast cancer?

Triple-negative breast cancer is a specific type of breast cancer that doesn't have three common features (receptors) that are often targeted by other breast cancer treatments. This makes it more challenging to treat, and new approaches are needed.

What is Globo H?

Globo H is a specific marker or sugar molecule that can be found on the surface of some cancer cells, including certain triple-negative breast cancers. The new vaccine in this study is designed to target this specific marker.

What is the purpose of a vaccine in cancer treatment?

In cancer treatment, a vaccine like the one in this study aims to teach your body's immune system to recognise and fight off cancer cells that carry specific markers, potentially preventing the cancer from coming back or growing.

Will I know if I'm getting the new vaccine or a standard treatment?

This study is "open-label," which means you and your doctors will know which treatment group you are in. This is different from some studies where participants don't know what they are receiving.

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra treatment given after the main treatment (like surgery or chemotherapy) for cancer. Its purpose is to kill any tiny remaining cancer cells and reduce the chance of the cancer coming back.