A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
This study is investigating a new medication, MCLA-158, for people with advanced cancers that have spread or come back. These include bowel cancer, head and neck cancer, and some stomach or gullet cancers. The main goals are to find the best and safest dose of MCLA-158 and to see how effective it is when given by itself or combined with existing cancer treatments like pembrolizumab or common chemotherapy drug combinations (FOLFIRI or FOLFOX). The study is also looking at side effects and how the drug acts in the body. It's currently in the later stages of finding the best dose and testing it in different cancer types.
At a glance
What is this study about?
This study is a clinical trial, which means it's a research study involving people. Its main focus is a new drug called MCLA-158. The researchers want to understand how this new drug works against advanced solid tumours – these are cancers that start in organs like the bowel, head and neck, or stomach, and have either spread to other parts of the body or are too advanced for surgery with the aim of cure. They are particularly interested in cancers that may depend on a specific pathway (called EGFR) for their growth.
The study is happening in two main parts. The first part, which has largely finished, was about finding the safest and most effective dose of MCLA-158 to use in future studies. This is called the 'recommended Phase II dose'. The second part of the study is now using that dose to see how well MCLA-158 works in different groups of patients, either on its own or in combination with other established cancer treatments. For example, it's being tested with pembrolizumab (a type of immunotherapy) and with common chemotherapy combinations like FOLFIRI or FOLFOX.
The overall aim is to gather important information about this new drug. This includes how safe it is, what side effects it might cause, how the body handles the drug (which is called pharmacokinetics), and crucially, how well it might shrink or slow down the cancer (its anti-tumour activity). This kind of research is vital for developing new ways to treat cancer and improve patient outcomes in the future.
Key takeaways
- Tests a new drug, MCLA-158, for advanced cancers.
- Aims to find the safest dose and see how well it works.
- Involves cancers like advanced bowel, head and neck, and stomach/gullet cancers.
- Treatment may be MCLA-158 alone or with other cancer drugs.
- Requires regular clinic visits for monitoring and tests.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, people generally need to have a solid tumour that has either spread or advanced to a point where standard treatments with the aim of cure are no longer an option. You would also need to be well enough to take part, meaning you can look after yourself and have healthy enough organs, including your heart.
For specific parts of the study, there are different requirements. For example, if you have advanced bowel cancer, your cancer cells must not have certain genetic changes (like in KRAS, NRAS, BRAF, or EGFR) and must be 'microsatellite stable'. If you have head and neck cancer, you might be eligible if you've had previous treatments that haven't worked and haven't tried certain other drugs before. The research team will do detailed tests to see if your cancer fits the study's specific criteria.
It's important to know that some groups of patients, for example, those with certain types of head and neck cancer who have received particular past treatments, might have been eligible in earlier parts of the study but those specific groups are now full.
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.
- Do I have an advanced solid cancer that has spread or recurred?
- Am I generally well enough to participate in a study (ECOG 0 or 1)?
- Have I been told that standard treatments to cure my cancer are not an option?
- Am I able to provide a recent tumour sample or have a biopsy if needed?
- Do I have a life expectancy of at least 12 weeks?
- Is my heart and other organ function healthy enough?
What does participation involve?
If you decide to take part in this study, you would receive the study drug, MCLA-158, either on its own or in combination with other treatments like pembrolizumab or chemotherapy (FOLFIRI or FOLFOX). These treatments are usually given through a drip into your arm at a clinic. The doses of MCLA-158 would typically be given every two weeks.
Throughout the study, you would have regular visits to the clinic. These visits will involve various tests and checks, such as blood tests, physical examinations, and scans (like X-rays or CT scans) to see how you're responding to the treatment and to monitor for any side effects. You might also need to provide fresh tissue samples from your tumour if it's safe and possible.
While the full duration isn't specified, these types of studies usually involve treatment for several months, with ongoing monitoring depending on how you respond. You would continue treatment for as long as it is working and you are tolerating it well, or until the study doctor decides it's no longer the best option for you. There would also be follow-up observations after you stop treatment.
Potential risks and benefits
Locations (45)
- UCSDVerified postcodeLa Jolla, United States· Recruiting
- USC Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Recruiting
- Sharp HealthcareVerified postcodeSan Diego, United States· Recruiting
- Rocky Mountain Cancer CentersVerified postcodeLone Tree, United States· Recruiting
- Florida Cancer SpecialistsVerified postcodeFort Myers, United States· Recruiting
- Sarah Cannon Research Institute (Lake Nona)Verified postcodeOrlando, United States· Recruiting
- Massachusetts General Hospital - Dana FarberVerified postcodeBoston, United States· Recruiting
- SSM Health Saint Louis University HospitalVerified postcodeSt Louis, United States· Recruiting
- Washington University School of Medicine at St LouisVerified postcodeSt Louis, United States· Recruiting
- Cayuga Medical CenterVerified postcodeIthaca, United States· Recruiting
- Hematology-Oncology Associates of Central New YorkVerified postcodeSyracuse, United States· Recruiting
- Cleveland ClinicVerified postcodeCleveland, United States· Recruiting
Common questions
What is MCLA-158?
MCLA-158 is a new investigational drug being tested to see if it can help treat certain advanced cancers by targeting specific pathways that might be helping the cancer grow.
What types of cancer is this study for?
This study is for people with advanced, solid tumours that have spread or come back, including certain types of advanced bowel cancer, head and neck cancer, and some stomach or gullet cancers.
Will I receive MCLA-158 on its own or with other drugs?
Depending on your specific cancer and which part of the study you join, you might receive MCLA-158 by itself, or in combination with other cancer treatments like pembrolizumab or chemotherapy (FOLFIRI or FOLFOX).
What does 'advanced solid tumour' mean?
This means a cancer that started in an organ (not a blood cancer) and has either spread to other parts of the body (metastatic) or is significantly grown locally that it can't be treated with surgery alone to cure it.
Can I stop participating in the study if I want to?
Yes, you have the right to leave the study at any time, for any reason, and this decision will not affect your future medical care.
How to find out more
Gianluca Laus, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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