Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors
This early-stage clinical trial is testing an experimental medicine called MCLA-129 for adults with advanced solid tumours, particularly non-small cell lung cancer. The study drug is a 'bispecific antibody', a treatment designed to stick to two specific proteins on cancer cells that help them grow and divide. The trial has two main goals. First, doctors want to find the safest and most effective dose of MCLA-129 and understand its side effects. Second, they want to see how well it works, either on its own or combined with standard cancer treatments like chemotherapy or targeted tablets such as osimertinib. Participants will have regular hospital visits for treatment, blood tests, and scans to closely monitor their health and track how their tumour responds. Taking part is voluntary, and people can leave the study at any time.
At a glance
What is this study about?
Solid tumours are cancers that form firm lumps in organs such as the lungs. When these cancers become advanced, they may spread to other parts of the body or stop responding to standard treatments. Because of this, researchers are working to find new, targeted treatments that can help people live longer with a good quality of life.
MCLA-129 is a new type of treatment known as a bispecific antibody. You can think of it like a key with two prongs. It attaches to two different proteins (called EGFR and c-MET) found on the surface of certain cancer cells. These proteins often send signals that tell the cancer to grow and spread. By attaching to both at the same time, MCLA-129 aims to block these growth signals and help the immune system fight the cancer.
This trial is running in two linked parts, known as Phase 1 and Phase 2. In the first part, a small number of patients receive slowly increasing doses to find the safest amount to give. In the second part, more patients receive that chosen dose to see how well it works at shrinking or controlling tumours. In some groups, the drug is tested on its own, while in others, it is combined with established cancer drugs such as chemotherapy or osimertinib.
Studies like this are vital for testing whether newer targeted drugs can offer better options for people whose cancer is hard to treat. The results help doctors understand whether MCLA-129 could become a standard treatment option in the future.
Key takeaways
- Testing a new targeted drug called MCLA-129 for advanced solid cancers, especially lung cancer.
- Aims to find the safest dose and see if it can slow down or shrink tumours.
- The drug may be given alone or combined with other cancer treatments like chemotherapy.
- Open to adults aged 18 and older who have tried other standard therapies.
- Participation is voluntary, and you can stop taking part at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have advanced solid tumours, including advanced non-small cell lung cancer. Generally, it is designed for people whose cancer has returned or continued to grow despite receiving standard treatments, or who have run out of suitable approved options.
To be considered, participants must be well enough to carry out daily tasks and attend regular hospital appointments. Their body organs, such as the heart, liver, and kidneys, must also be working well enough to handle the trial medicines safely.
People might not be able to join if they have certain active infections, other uncontrolled medical conditions, or severe side effects from past cancer treatments. The hospital study team will carry out detailed health checks to make sure joining the trial is safe for each individual.
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.
- I am aged 18 or older.
- I have been diagnosed with an advanced solid tumour or non-small cell lung cancer.
- My cancer has grown or returned after previous treatments, or I have no standard options left.
- I am well enough to look after myself and travel to hospital appointments.
- I am willing to have regular scans, blood tests, and intravenous treatments.
What does participation involve?
Taking part in this study involves regular visits to a specialist hospital centre. The main study drug, MCLA-129, is given directly into a vein through a drip (infusion). Depending on which study group you join, you may also receive standard chemotherapy through a drip or take cancer tablets by mouth at home. During clinic visits, the care team will check your vital signs, take blood and urine samples, and ask about any symptoms or side effects you feel. You will also have regular imaging scans, such as CT or MRI scans, every few weeks to check whether your tumour has changed in size. Treatment usually continues for as long as it is helping and side effects remain manageable. After stopping the treatment, the study team will continue to check on your health through follow-up visits or phone calls.
Potential risks and benefits
Locations (6)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedGermany
Common questions
What is a bispecific antibody?
It is a laboratory-made protein designed to latch onto two specific targets on cancer cells at the same time, helping to block growth signals and alert your immune system.
Do I have to pay to take part in this trial?
No. The trial medicine and all study-related tests are provided free of charge, and some trials can help cover travel expenses to and from the hospital.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw at any time, for any reason, without it affecting your ongoing cancer care.
How often will I need to visit the hospital?
Visits are typically more frequent at the start, sometimes once a week or every two weeks, to give the drip and check your health. Your team will give you a clear schedule.
Will this trial cure my cancer?
This study is aimed at controlling advanced cancer rather than offering a guaranteed cure. The goal is to see if the drug can safely shrink tumours or slow their growth.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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