Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
This is a very early study (Phase 1) looking at a new medicine called AMG 305. It's the first time this medicine is being given to people. We are inviting adults who have advanced solid cancers, such as certain types of lung, pancreatic, head and neck, ovarian, cervical, uterine, and breast cancer, as well as mesothelioma. The main goals are to find out if the medicine is safe, what dose people can comfortably take, and how the body processes the medicine. This kind of study helps us understand if the new medicine has the potential to be a future treatment option for these cancers.
At a glance
What is this study about?
This study is called a 'First-In-Human' Phase 1 trial. This means it's the very first time this new medicine, AMG 305, is being given to people. The main purpose of this early stage is to carefully check if the medicine is safe to use and to see how the body reacts to it. We also want to find out the highest dose that people can safely tolerate without too many side effects.
The study is for adults who have advanced solid tumors. This includes several types of cancer that have spread or are difficult to treat, such as lung, pancreatic, breast, ovarian, cervical, uterine, and head and neck cancers, as well as mesothelioma. These are called 'solid tumors' because they form a solid mass, as opposed to blood cancers.
By taking part, you would be helping researchers learn important information about this new medicine. Understanding its safety and how it works in the body is a crucial first step before it can be tested in larger groups of people to see if it truly helps treat these cancers. This research could pave the way for new treatment options in the future.
Key takeaways
- This is an early-stage study (Phase 1) of a new medicine, AMG 305.
- It's the first time this medicine is being given to people.
- The main goals are to check safety and how the body handles the medicine.
- The study is for adults with advanced solid cancers like lung, pancreatic, and breast cancer.
- Participation involves receiving the medicine and having regular health checks.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 years or older. Both men and women are welcome to take part.
Another important requirement is that you must have a type of advanced solid cancer. This includes specific cancers such as non-small cell lung cancer, mesothelioma, pancreatic cancer, head and neck cancer, ovarian cancer, cervical cancer, uterine cancer, or breast cancer that has progressed or is advanced. The study team will review your medical history and current health carefully to make sure the study is a good fit for you.
There will also be other specific medical criteria, like certain health test results or previous treatments, that the doctors will need to check to ensure your safety if you join 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.
- Are you 18 years old or older?
- Do you have a type of advanced solid cancer (e.g., lung, pancreatic, breast, ovarian, cervical, uterine, head and neck cancer, or mesothelioma)?
- Are you able to attend appointments at the study clinic regularly?
- Are you willing to follow all study instructions and procedures?
- Have you discussed this study with your current doctor?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, AMG 305. This is an early study, so the exact dose and how it’s given will be carefully managed. You will have regular appointments at the study clinic, where doctors and nurses will monitor your health very closely.
During these visits, you will have various tests, such as blood tests, scans, and physical examinations. These tests help the doctors understand how your body is responding to the medicine, whether it's causing any side effects, and how the medicine is moving through your system. You will also be asked about any symptoms you experience.
The total duration of the study, including follow-up appointments after you stop taking the medicine, will be explained in detail by the study team. They will also tell you how often you need to visit the clinic.
Potential risks and benefits
Locations (3)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What does 'Phase 1' mean?
Phase 1 means this is the very first time the new medicine is being tested in humans. The main goal is to check its safety and how the body handles it.
What kinds of cancer are included?
This study is for people with advanced solid cancers like lung, pancreatic, breast, ovarian, cervical, uterine, and head and neck cancers, as well as mesothelioma.
Will this medicine cure my cancer?
It's too early to say if this medicine will cure cancer. The main goal of this study is to see if it's safe, not to prove it's a cure.
What are the biggest risks?
The biggest risks are potential side effects, some of which may not be known yet, because it's a new medicine. The study team will monitor you very closely.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason. It won't affect your regular medical care.
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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