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Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Colorectal Cancer

This research is a clinical trial exploring new ways to treat advanced bowel cancer, which is cancer that has spread to other parts of the body. Doctors are testing new drug combinations, including drugs called Etrumadenant and Quemliclustat, alongside standard treatments like chemotherapy (FLUOROURACIL, OXALIPLATIN, CALCIUM FOLINATE) and other medications (BEVACIZUMAB, Zimberelimab, REGORAFENIB). The study wants to find out if these new combinations can help control the cancer for longer, shrink the tumours, and improve how patients feel overall. It will also look carefully at any side effects to make sure the treatments are safe.

At a glance

Status
Ongoing, recruiting
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Arcus Biosciences Inc.
Enrolment target
57
Start
30 Sep 2024

What is this study about?

This study is a clinical trial focusing on people who have advanced bowel cancer, also known as metastatic colorectal cancer. This means the cancer has spread from where it started to other areas of the body. The main goal of this research is to find new and more effective ways to treat this type of cancer. Researchers are testing different combinations of new drugs with existing standard treatments. The hope is that by combining these medications, they might be able to control the cancer better and for longer.

The study involves several different treatment combinations, and it's set up to carefully compare how well these new approaches work against each other and against current treatments. Doctors will be looking at important factors like how long the cancer is kept under control, whether tumours shrink, and overall how long people live. They'll also be closely monitoring any side effects to understand the safety of these new drug combinations.

By taking part in studies like this, patients contribute to medical knowledge that can help future patients with advanced bowel cancer. The information gathered will help doctors understand which treatments are most promising and safe, potentially leading to better care options down the line.

Key takeaways

  • This study is for advanced bowel cancer that has spread.
  • It's testing new drug combinations to see if they are safer and more effective.
  • Doctors will monitor how well the treatments work and any side effects.
  • Participation could last for several years to track long-term effects.
  • You can stop participating at any time you wish.
  • The information learned could help future patients with advanced bowel cancer.

Who may be eligible?

To join this study, people generally need to be at least 18 years old. Both men and women are welcome to take part.

You would need to have been diagnosed with bowel cancer that has spread to other parts of your body. Doctors will check your overall health and previous treatments to make sure this study is right for you, as there are specific criteria about your cancer type and how well your body is coping.

It's important to discuss your full medical history with the study doctors. They will explain all the details and confirm if you meet all the requirements for this particular research programme.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with bowel cancer that has spread (metastatic colorectal cancer)?
  3. Are you generally well enough to try new treatments?
  4. Are you willing to attend regular hospital visits for tests and check-ups?
  5. Have you discussed your previous treatments and current health with your doctor?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving one of the study drug combinations, which might include new treatments or standard care. You would have regular appointments for check-ups, blood tests, and scans (like CT or MRI) to monitor your cancer and your general health. These appointments will help doctors see how the treatment is working and make sure you're doing okay.

The study will last for an extended period, potentially between three to seven years, to track the long-term effects of the treatments. However, your involvement in active treatment and monitoring for side effects might be more concentrated during the initial 10 months. You'll have the right to withdraw from the study at any time.

Potential risks and benefits

Potential benefits could include access to new treatments that might be more effective than standard options, and your participation helps advance medical science for future patients. However, there are potential risks, as new drugs can have side effects that are not fully known, or the treatments might not work for everyone. The study team will carefully monitor you for any problems. You have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

Common questions

What type of cancer is this study for?

This study is for advanced bowel cancer, specifically metastatic colorectal cancer, which means the cancer has spread to other parts of the body.

What kinds of treatments are being tested?

The study is testing new combinations of drugs, including existing treatments like chemotherapy, alongside newer experimental medications like Etrumadenant and Quemliclustat.

How long will I be involved in the study?

The study will track patients for a long time, potentially between three and seven years, to see the long-term effects. The main treatment and close monitoring for side effects would typically be during the first 10 months.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Will I receive a new treatment or a standard one?

This study involves different groups, and you might receive a combination of new experimental drugs, standard treatments, or both. Your doctor will explain which group you could be in.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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