First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
This study is a first-time test in people to see if a new drug, TUB-030, can help adults with advanced solid cancers. The main goals are to check how safe TUB-030 is, how well people tolerate it, and to find the highest dose that can be given without causing too many side effects. Researchers will also look at whether TUB-030 helps treat certain cancers like head and neck cancer and a type of lung cancer. Participants will receive the drug every three weeks and visit the clinic for checkups and tests. They will also share how they are feeling through questionnaires. This study is an important first step in understanding if TUB-030 could become a useful treatment in the future.
At a glance
What is this study about?
This research study is looking into a new drug called TUB-030, designed for adults who have advanced solid cancers. When we say 'advanced solid cancers,' we mean cancers that have grown or spread in the body, such as head and neck cancer, small cell lung cancer, non-small cell lung cancer, triple-negative breast cancer, and colorectal cancer. This is a very early stage study, often called a 'first in human' study, which means it’s the first time this drug is being tested in people.
The main aims of the study are to understand two key things: firstly, how safe TUB-030 is for patients and if it causes side effects, and secondly, to figure out the best and safest amount, or 'dose,' of the drug to give. Researchers will also be checking if TUB-030 seems to have any effect on the cancer itself. They'll pay special attention to two specific types of cancer in this study: head and neck cancer and a form of lung cancer, to see how the drug works for them.
By taking part, you would be helping doctors and scientists learn more about this new treatment. This information is really important because it helps decide if TUB-030 should be studied further in the hope that it could eventually become a new treatment option for people with these cancers.
Key takeaways
- This study is testing a new drug, TUB-030, for adults with advanced solid cancers.
- The main goals are to check the drug's safety, side effects, and find the right dose.
- Participation involves receiving the drug and having regular clinic visits every three weeks.
- Your feedback on symptoms through questionnaires is an important part of the study.
- You can stop participating at any time without affecting your medical care.
- This is an early-stage study, so the drug’s effects are still being investigated.
Who may be eligible?
To join this study, you need to be an adult aged 18 or over. Your body's organs, like your kidneys and liver, need to be working well enough. If you’ve had other cancer treatments recently, there needs to be a specific amount of time passed since your last dose – usually at least four weeks, depending on the treatment. Any side effects from your previous treatments, radiotherapy, or surgery must have mostly cleared up.
If you have cancer that has spread to your brain, it needs to be stable and not getting worse after any previous treatment. Similarly, if you’ve had radiotherapy to other parts of your body, enough time must have passed. Your cancer needs to be measurable on scans so doctors can see if the treatment is working. You should also be generally well enough to take part in the study activities, and the research team will assess whether you’re expected to live for more than 12 weeks.
Finally, you must be able to understand the study details and give your informed consent, which means agreeing to take part after all your questions have been answered. For women who might be able to have children, or who are sexually active, you'll need to use very effective birth control during and for a period after the study. This also applies to men for a certain time.
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?
- Are your major organs (like liver and kidneys) working well enough?
- Has it been at least 4 weeks since your last cancer treatment (if applicable)?
- Are any side effects from previous treatments mostly cleared up?
- Do your doctors believe you are well enough to take part and have more than 12 weeks of life expectancy?
- For women who could have children, are you willing to use effective birth control during and after the study?
What does participation involve?
If you decide to take part in this study, you will receive the study drug, TUB-030, once every three weeks. On these days, you will come to the clinic for your treatment, along with check-ups and various tests to monitor your health and how the drug is affecting you. You will also be asked to fill out questionnaires about how you are feeling and any symptoms you might have. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but you will receive the drug and have check-ups every three weeks.
Potential risks and benefits
Locations (16)
- Yale Cancer CenterVerified postcodeNew Haven, United States· Recruiting
- University of MiamiVerified postcodeMiami, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
- Washington UniversityVerified postcodeSt Louis, United States· Recruiting
- Mount SinaiVerified postcodeNew York, United States· Recruiting
- Cleveland ClinicVerified postcodeCleveland, United States· Recruiting
- Ohio State UniversityVerified postcodeColumbus, United States· Recruiting
- NEXT Oncology AustinVerified postcodeAustin, United States· Recruiting
- NEXT Oncology - DallasVerified postcodeIrving, United States· Recruiting
- NEXT Oncology - San AntonioVerified postcodeSan Antonio, United States· Recruiting
- Fred Hutchinson Cancer CenterVerified postcodeSeattle, United States· Recruiting
Common questions
What does 'advanced solid tumors' mean?
It means the cancer is present in organ tissue and may have grown or spread to other parts of your body. Examples include certain types of lung, breast, and bowel cancer.
What is a 'Phase 1/2 study'?
This means it's an early-stage study. Phase 1 focuses on finding a safe dose and understanding side effects. Phase 2 then looks at whether the drug has a positive effect on the cancer for specific types of cancer.
Will I know if the drug is working?
The study involves regular check-ups and tests, such as scans, which will help your medical team assess how the drug is affecting your cancer. They will discuss these results with you.
What if I experience side effects?
You will be closely monitored by the study team. Any side effects you experience will be carefully managed, and you should tell your medical team about any changes in how you feel.
What does 'patient reported outcome questionnaires' involve?
These are simply forms where you answer questions about your symptoms, your well-being, and how you are feeling, which helps the research team understand the impact of the drug on your daily life.
How to find out more
Tubulis Clinical Trial Inquiries
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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