All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination

This research study is testing a new medicine called MCLA-129 for people with advanced cancers, such as non-small cell lung cancer, stomach cancer, or other solid tumours. The main goals are to find a safe and effective dose of MCLA-129, and to see how well it works. This new drug will be given either alone or combined with existing treatments like osimertinib or chemotherapy. The study is open to adults aged 18 and over who have either not had treatment before or whose cancer has continued to grow despite earlier treatments. The study is split into two parts: the first part focuses on finding the right dose, and the second part looks more closely at how effective the drug is. Researchers hope this new medicine could offer a new treatment option for these types of advanced cancers.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Merus B.V.
Enrolment target
194
Start
28 Apr 2021
Estimated completion
01 Mar 2027

What is this study about?

This study is looking at a new medicine called MCLA-129. This medicine is designed to work against certain types of advanced cancers, including non-small cell lung cancer, stomach cancer, a type of throat cancer (oesophageal squamous cell carcinoma), head and neck cancer, and bowel cancer, as well as other solid tumours. We want to find out if this new medicine is safe and how well it works in people whose cancer has either come back or gotten worse despite previous treatments.

The study has two main stages. In the first stage, a small group of people will receive different doses of MCLA-129 to help us find the safest and most effective amount to give. Once we've found that, the second stage will involve more people and will look more closely at how well MCLA-129 works to treat their cancer. We'll be testing MCLA-129 on its own and also in combination with other standard cancer treatments, such as osimertinib or chemotherapy, to see if combining them gives better results.

Taking part in a study like this helps us learn more about new treatments. By finding better ways to fight cancer, we hope to improve the lives of people living with these conditions. It's important to remember that this is a research study, and while we hope for positive outcomes, we are still learning about this new medicine.

Key takeaways

  • This study is testing a new drug, MCLA-129, for some advanced cancers.
  • It aims to find a safe and effective dose, alone or with other treatments.
  • It's for adults (18+) who have had previous cancer treatments.
  • Participation involves regular hospital visits for check-ups and treatment.
  • You might experience side effects, and the treatment might not work for everyone.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over. In the first part of the study, we are looking for people with non-small cell lung cancer, stomach cancer, head and neck cancer, or a type of throat cancer (oesophageal squamous cell carcinoma) who have already tried standard treatments, and these treatments either didn't work for them or they couldn't tolerate them. You can have had many previous treatments, there isn't a limit.

In the second part of the study, we are looking for people with non-small cell lung cancer, head and neck cancer, or other types of solid tumours, where your doctor has identified specific changes in your cancer cells (called applicable mutations).

To join, you'll need to provide a sample of your cancer tissue. Your cancer must be measurable on scans, and you should be generally well enough to take part in daily activities (we use a special scale for this, and you'd need to meet specific criteria). We also need to be sure your body's organs are working properly, and your doctor thinks you are likely to live for at least 12 weeks. There are some specific health conditions that would prevent you from joining, such as untreated brain tumours or having had major surgery or radiotherapy too recently.

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 non-small cell lung cancer, stomach, head and neck, throat, bowel or other solid tumour?
  3. Have you already tried standard treatments for your cancer?
  4. Are your organs (like your liver and kidneys) generally working well?
  5. Do you have measurable cancer on scans and feel well enough for normal daily activities?
  6. Do you not have untreated brain tumours or recent major surgery/radiotherapy?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new study drug, MCLA-129. You'll have regular hospital visits for check-ups, scans, and blood tests to monitor your health and how your body is responding to the treatment. These visits will help us understand if the medicine is working and if there are any side effects. The study involves taking the medicine over a period and having follow-up appointments. The exact number of visits and the total length of time you'll be in the study will depend on which part of the study you are in and how you respond to the treatment. Your study team will explain everything to you in detail.

Potential risks and benefits

Participating in this study might offer you a chance to try a new treatment that isn't widely available yet. While we hope for a positive effect on your cancer, we can't guarantee that the treatment will work for you. As with any medicine, MCLA-129 might have side effects, and some could be serious. The study team will explain all known side effects and monitor you very closely. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (51)

  • University of California, Irvine
    Verified postcode
    Orange, United States
  • Sarah Cannon Research Institute
    Verified postcode
    Nashville, United States
  • START Mountain Region
    Verified postcode
    West Valley City, United States
  • Next Oncology Virginia
    Verified postcode
    Fairfax, United States
  • Institut Jules Bordet
    Verified postcode
    Anderlecht, Belgium
  • Antwerp University Hospital
    Verified postcode
    Edegem, Belgium
  • Clinique de l'Europe
    Verified postcode
    Amiens, France
  • CHU Hopitaux de Bordeaux - Hôpital Saint-André
    Verified postcode
    Bordeaux, France
  • CHU de Lyon - Louis Pradel Hospital
    Verified postcode
    Bron, France
  • Centre Hospitalier Intercommunal de Créteil
    Verified postcode
    Créteil, France
  • Hôpital Albert Calmette
    Verified postcode
    Lille, France
  • L'Institut Paoli - Calmettes
    Verified postcode
    Marseille, France

Common questions

What is MCLA-129?

It's a new experimental medicine being tested to treat certain advanced cancers, designed to target specific features of cancer cells.

What types of cancer is this study for?

It's for advanced non-small cell lung cancer, stomach cancer, a type of throat cancer, head and neck cancer, bowel cancer, and some other solid tumours.

Can I join if I've had previous treatments?

Yes, many people in this study have already tried other treatments that either didn't work or caused too many problems.

What are the main goals of the study?

The study aims to find a safe dose of MCLA-129 and see how well it works, both alone and with other medicines.

Will I get MCLA-129 or a placebo?

Everyone in this study will receive MCLA-129, either on its own or with other standard cancer treatments.

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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