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RecruitingPHASE1INTERVENTIONAL

A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors

This early-stage study, called a Phase 1 trial, is investigating a new medication named IPH5301 for patients with advanced cancers that have spread, such as breast, stomach, lung, and ovarian cancer. It's the first time this drug is being tested in humans. The main goals are to find a safe and effective dose of IPH5301, both when given by itself and when combined with standard chemotherapy and a drug called trastuzumab. The study will first identify a safe dose, and then explore how well it works in a small group of breast cancer patients. This research is crucial for understanding if IPH5301 could become a future treatment option.

At a glance

What is this study about?

This study is a very early investigation into a new drug called IPH5301. It's designed for people with advanced cancers that have spread to other parts of the body, such as breast, stomach, lung, and ovarian cancers. Because it's a 'first-in-human' study, it means that this is the first time IPH5301 is being given to people. The main purpose is to carefully check if the drug is safe and to figure out the right amount (dose) to give.

The study will happen in two main parts. In the first part, a small group of patients will receive IPH5301, starting with very low doses, which will be slowly increased. This helps the doctors find the highest dose that can be given without causing too many serious side effects, known as the 'maximum tolerated dose,' and also recommend a dose for future studies. The second part will focus on a specific group of breast cancer patients whose cancer has too much of a protein called HER2. These patients will receive IPH5301 along with standard chemotherapy and another drug called trastuzumab. The aim here is to see how safe and effective this combination is, and to help choose the best dose for future, larger studies.

This research is a vital step in developing new treatments for cancer. It helps doctors understand how IPH5301 works in the body, what side effects it might have, and if it could potentially help patients when combined with other medicines. Every new cancer treatment goes through careful steps like this to ensure it's safe and has the potential to be helpful.

Key takeaways

  • It's a very early-stage study (Phase 1) testing a new drug called IPH5301.
  • The main goals are to find a safe dose and understand how the drug works.
  • It's for people with advanced, spread cancer that hasn't responded to other treatments.
  • Patients may receive IPH5301 alone or with chemotherapy and trastuzumab.
  • Regular check-ups and monitoring will be part of taking part.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and older who have advanced cancer that has spread and cannot be cured by existing treatments. Your doctors must agree that a Phase 1 study is a suitable option for you.

In the first part of the study, patients with advanced breast, stomach, oesophageal, pancreatic, womb, ovarian, or lung cancer are being considered. You must have already tried at least one standard treatment for your cancer that didn't work or stopped working.

For the second part of the study, the focus is on patients with advanced breast cancer that has specific characteristics related to a protein called HER2 (either "HER2-positive" or "HER2-low"). These patients must also have already received (or be unable to have) all standard treatments for their type of breast cancer.

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. Do you have advanced cancer that has spread?
  3. Has your cancer been treated with standard therapies that are no longer working or suitable?
  4. Has your doctor confirmed that a Phase 1 study is an appropriate option for you?
  5. If you have breast cancer, does it fit specific criteria related to the HER2 protein?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new study drug, IPH5301. Depending on which part of the study you join, you might receive IPH5301 on its own, or in combination with standard chemotherapy and trastuzumab. As this is an early-stage study, you will have frequent visits to the clinic so the medical team can closely monitor your health and how you respond to the treatment. This will involve various assessments, including blood tests, scans, and physical examinations. The total duration of your participation will depend on how you respond to the treatment and the study's design, but early-phase studies often involve close monitoring for several months.

Potential risks and benefits

Taking part in a clinical trial like this could potentially offer you access to a new treatment before it's widely available. While IPH5301 is new, and its full benefits and risks are not yet known, it's hoped that it might help slow down the cancer or improve symptoms. However, like all medicines, IPH5301 could have side effects, some of which might be serious. The medical team will monitor you very closely for any side effects and will explain all known risks before you make a decision. Importantly, you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Institut Paoli Calmettes
    Verified postcode
    Marseille, France· Recruiting

Common questions

What does 'Phase 1' mean?

Phase 1 means it's one of the first human trials for a new drug. The main goal is to find a safe dose and see how the body handles the medicine.

What is IPH5301?

IPH5301 is a new experimental drug that targets a specific protein in the body. Researchers hope it might help fight advanced cancer.

What kind of cancers is this study for?

This study is for advanced metastatic cancers such as breast, stomach, pancreatic, lung, oesophageal, womb, and ovarian cancer.

Will I get IPH5301 on its own or with other drugs?

Depending on which part of the study you join, you might receive IPH5301 by itself or together with standard chemotherapy and another drug called trastuzumab.

Can I leave the study if I change my mind?

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

How to find out more

DOMINIQUE GENRE

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 "A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alon…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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