Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
This research is looking at a new drug called RO7247669 for people with advanced cancers that have spread. It's the first time this drug is being tested in humans. The main goals are to find the highest safe dose of the drug and to see how well it works against different types of cancer, particularly certain melanomas, lung cancers, and oesophageal cancers. The study will also check how the body handles the drug and if it shows early signs of shrinking tumours. Once the best dose is found, more people with specific cancers will be invited to join to further study the drug's effects and safety. This drug is a type of 'bispecific antibody' that helps your immune system fight cancer cells more effectively.
At a glance
What is this study about?
This study is exploring a new medicine named RO7247669 for individuals with advanced or metastatic solid tumours. 'Advanced' means the cancer has grown or spread, and 'metastatic' means it has spread from where it started to other parts of the body. The drug is a special type of antibody, which is a protein that can recognise and attach to specific targets, in this case, on cancer cells or immune cells. This particular drug is designed to help your body's own immune system recognise and fight the cancer more effectively.
Because this is a new drug, the first step is to carefully find the best dose. This means starting with a very small amount and gradually increasing it in different groups of people, while closely monitoring for any side effects. This part of the study is called 'Phase 1' and helps researchers understand how safe the drug is at different doses and what the highest dose is that people can tolerate. They will also learn how the body takes in, uses, and gets rid of the drug, and if it has any effect on the cancer.
Once a suitable dose is identified, the study will move into a 'Phase 2' part, where more people with specific types of cancer, like melanoma, non-small cell lung cancer, and oesophageal cancer, will be included. This phase will further check the drug's safety and effectiveness at the chosen dose, looking to see if it can help stop the cancer from growing or even shrink the tumours. The ultimate goal is to find new ways to treat these challenging cancers.
Key takeaways
- Tests a new drug (RO7247669) for advanced solid tumours.
- Aims to find the safest and most effective dose.
- Focuses on melanoma, lung, and oesophageal cancers.
- Involves close monitoring for side effects and tumour changes.
- Is a 'first-in-human' study, meaning it's new and untested.
Who may be eligible?
To join this study, you generally need to have an advanced solid tumour, which means it has grown or spread, and other treatments haven't worked or aren't suitable for you. You should also be well enough to take part in daily activities, meaning you have a good 'performance status'.
There are also specific requirements depending on the type of cancer you have. For example, if you have melanoma, it needs to be at an advanced stage and you can't have had more than two previous treatments for it. You also must have already received a specific type of immunotherapy.
For non-small cell lung cancer, you might be eligible if you've had up to two previous treatments, including a specific immunotherapy, or if you haven't been treated for metastatic disease yet but your tumour shows particular markers. If you have oesophageal cancer, you can't have had more than one previous treatment for the advanced stage. All participants need to be at least 18 years old. Both men and women can participate, but women who could become pregnant and male partners must agree to use effective birth control during the study.
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 tumour that has spread?
- Have other standard treatments not worked or are not suitable for me?
- Am I generally well enough to take part in daily activities?
- If I am a woman, am I able to use effective contraception, or am I past childbearing age? If I am a man, am I able to use effective contraception?
- Is my cancer type one of those listed (melanoma, non-small cell lung cancer, oesophageal cancer)?
- Have I had the right number of previous treatments for my specific cancer type?
What does participation involve?
If you join this study, you'll receive the new drug called RO7247669. Because this is a dose-finding study, you'll be one of the first people to receive this drug, and the amount you receive might be slowly increased over time, always with your safety as the top priority. You will have regular appointments for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The exact number of visits and tests will be explained by the study team.
During the study, you'll be closely monitored by a team of doctors and nurses. This might involve giving blood samples, having tumour biopsies (small tissue samples) if needed, and undergoing various scans like CT or MRI to track your cancer's progress. You will continue to receive the study drug for as long as it is safe and you are benefiting, or until your doctor decides it's no longer the best option for you. After stopping the treatment, there will be follow-up appointments to check on your health. The total time you're involved could vary, but the study team will let you know what to expect.
Potential risks and benefits
Locations (25)
- RigshospitaletVerified postcodeKøbenhavn Ø, Denmark
- Odense Universitetshospital, Onkologisk Afdeling RVerified postcodeOdense C, Denmark
- LLC Arensia Explorer MedicineVerified postcodeTbilisi, Georgia
- Hadassah University Hospital - Ein KeremUnverifiedJerusaelm, Israel
- Rabin MCVerified postcodePetah Tikva, Israel
- Chaim Sheba medical center, Oncology divisionVerified postcodeRamat Gan, Israel
- Hospital Civil de Guadalajara Fray Antonio AlcaldeVerified postcodeGuadalajara, Mexico
- Inst. Nacional de CancerologíaVerified postcodeMexico City, Mexico
- Consultorio Médico Jordi Guzmán CastaVerified postcodeQuerétaro City, Mexico
- National University HospitalVerified postcodeSingapore, Singapore
- National Cancer CentreVerified postcodeSingapore, Singapore
- Seoul National University Bundang HospitalVerified postcodeSeongnam-si, South Korea
Common questions
What kind of cancers is this study for?
This study is for people with advanced solid tumours that have spread, including specific types of melanoma, non-small cell lung cancer, and oesophageal cancer.
Is this drug new?
Yes, RO7247669 is a new drug being tested in humans for the first time in this study.
What is a 'dose escalation study'?
It means the study starts with a low dose of the drug in a small group of people and slowly increases the dose in new groups to find the safest and most effective amount.
Will I have to have biopsies?
Fresh biopsies (small tissue samples) might be needed during the study to learn more about your cancer and how the drug is working.
Can I leave the study if I want to?
Yes, you can choose to stop participating in the study at any time, for any reason, and your medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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