All studies
RecruitingPHASE1INTERVENTIONAL

ARC101 in Advanced Solid Tumors

This research study is looking at a new medicine called ARC101 for people who have advanced forms of certain cancers, including ovarian, testicular, or other cancers that have a specific marker called Claudin 6. It's the very first time this medicine is being tested in humans. The main goals are to find out if ARC101 is safe to use, what side effects it might cause, and how the body processes it. Researchers also want to see if ARC101 can help slow down or stop cancer growth. Because it's a new medicine, the study will carefully monitor participants to understand its effects and whether it could be a helpful treatment option in the future.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Third Arc Bio
Enrolment target
70
Start
05 Feb 2025
Estimated completion
01 Aug 2028

What is this study about?

This study is about a new medicine called ARC101 that doctors hope might help people with advanced cancer. When we say "advanced cancer," it means the cancer has spread or is difficult to treat with standard methods. This particular study is for cancers like ovarian, testicular, and other specific cancers that have a special feature called Claudin 6. Think of Claudin 6 as a kind of flag on the cancer cells that ARC101 is designed to target.

This is a "first-in-human" study. This means it's the very first time this new medicine, ARC101, is being given to people. Because of this, it's a very important step in developing new treatments. The main purpose is to learn as much as possible about ARC101. Doctors will be checking very carefully to see if it's safe, what kinds of side effects people might experience, and how the body handles the medicine.

Beyond safety, researchers are also hoping to see if ARC101 can actually help to stop the cancer from growing or even shrink it. Finding new treatments for advanced cancers is really important, and studies like this help us understand if new medicines could be a good option for patients in the future.

Key takeaways

  • This study is testing a brand-new medicine, ARC101, for advanced cancers.
  • It's the first time ARC101 has been given to humans, focusing on safety and how the body reacts.
  • It's for specific advanced cancers (ovarian, testicular, or others with a 'Claudin 6' marker).
  • Participation means receiving the new medicine under close medical supervision.
  • You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you would need to have certain advanced solid cancers, such as ovarian, testicular, or other similar cancers that show a specific marker called Claudin 6. Doctors will need to be able to measure or assess your cancer. You should also generally be in good health for someone with cancer, meaning you can mostly look after yourself and are able to move around without too much difficulty, and your body's main organs (like your liver and kidneys) are working well.

There are also reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you've recently been diagnosed with another type of cancer that isn't the one being studied. If you have a lot of fluid build-up in your tummy (called ascites) that isn't controlled, or if you're still experiencing bad side effects from previous cancer treatments, you might not be eligible.

Other reasons for not being able to take part include serious lung problems, certain autoimmune diseases that flare up, or if you are pregnant, breastfeeding, or planning to have children soon. The medical team will carefully review all these details with you to see if this study is suitable.

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. Do I have advanced ovarian, testicular, or another solid cancer with the Claudin 6 marker?
  2. Can my cancer be measured or assessed by doctors?
  3. Am I generally active and able to look after myself most of the time?
  4. Are my main organ functions (like liver and kidneys) working well?
  5. Do I not have active cancer spread to my brain or spinal cord?
  6. Am I not pregnant, breastfeeding, or planning to have children soon?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the new medicine, ARC101. The study team will regularly check your health status through various tests, including blood tests, scans, and physical exams, to monitor how your body is responding to the medicine and to look for any side effects. You'll have scheduled clinic visits for these checks. The total duration of your participation will depend on how you respond to the treatment and what the study doctors decide is best for your care, but you would have regular follow-up for a period after your last dose. The exact number of visits, tests, and the overall length will be fully explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment, ARC101, that is not yet widely available and which might help control your cancer. However, as this is a new medicine, there are also risks. We don't yet know all the possible side effects, and some could be serious. The study doctors will carefully monitor you for any problems. It's very important to remember that you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

  • Massachusetts General Hospital
    Verified postcode
    Boston, United States· Recruiting
  • START Midwest
    Verified postcode
    Grand Rapids, United States· Recruiting
  • START San Antonio, LLC.
    Verified postcode
    San Antonio, United States· Recruiting
  • Sunshine Coast University Private Hospital
    Verified postcode
    Birtinya, Australia· Recruiting
  • Cancer Research SA
    Verified postcode
    Adelaide, Australia· Recruiting
  • Cabrini Health Research
    Verified postcode
    Malvern, Australia· Recruiting
  • BC Cancer Research Centre
    Verified postcode
    Vancouver, Canada· Recruiting
  • The Princess Margaret Cancer Centre
    Verified postcode
    Toronto, Canada· Recruiting
  • McGill University Health Centre
    Verified postcode
    Montreal, Canada· Recruiting
  • Rambam Medical Center
    Verified postcode
    Haifa, Israel· Recruiting
  • Sheba Medical Center
    Verified postcode
    Ramat Gan, Israel· Recruiting
  • Sourasky Medical Center
    Verified postcode
    Tel Aviv, Israel· Recruiting

Common questions

What is ARC101?

ARC101 is a new experimental medicine being tested for advanced cancer. It's the first time it's being given to people.

What kind of cancers is this study for?

This study is for advanced ovarian, testicular, or other solid cancers that have a specific marker called Claudin 6.

Why is this called a 'first-in-human' study?

It's called 'first-in-human' because it's the very first time this new medicine is being tested in people. This helps doctors understand its safety and effects.

Will I definitely get the medicine if I join?

If you meet all the eligibility criteria, you would receive ARC101. There isn't a placebo group in this type of early study.

Can I leave the study at any time?

Yes, you have the right to leave the study at any point, and it won't affect your ongoing medical care.

How to find out more

VP Clinical Operations

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

Interested in taking part?

Register your interest

Share your details and the research team for "ARC101 in Advanced Solid Tumors…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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