A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
This study (called "first-in-human") is testing a new medication, IMP1734, for people with advanced solid tumours, which are cancers that have spread. The main goals are to find out if the drug is safe, what side effects it might cause, and how much of it the body can handle. It also looks at how the drug moves through the body and if it shows any early signs of helping to treat the cancer. The study involves two main parts: first, gradually increasing the dose to find the safest and most effective amount, and then testing that dose further. This is an important early step in developing new cancer treatments.
At a glance
What is this study about?
This research is looking at a new medicine called IMP1734. It's for people who have advanced solid cancers, which means their cancer has grown or spread. This kind of study is called a "first-in-human" study because it's one of the first times this specific drug is being given to people. The main idea is to understand if IMP1734 is safe to use, what kind of side effects it might cause, and how much of it is the right amount to give.
The study has two main parts. In the first part, called "dose escalation," a small group of people will start with a very low dose of IMP1734. The doctors will carefully watch for any side effects and gradually increase the dose in different groups of people until they find the highest dose that is safe and can be tolerated. This part focuses on breast, ovarian, and prostate cancers. The second part of the study will then use the best dose found in the first part to gather more information about its safety and whether it shows any promise in treating these cancers.
Finding new ways to treat advanced cancers is very important. Studies like this help scientists learn if a new drug could be a helpful option in the future. It’s an early stage of research, but it's a crucial step in trying to find better treatments for people living with cancer.
Key takeaways
- Tests a new medicine (IMP1734) for advanced cancers.
- Aims to check safety, side effects, and best dose.
- Primarily for specific advanced breast, ovarian, and prostate cancers.
- Involves regular health checks and monitoring.
- Participation is voluntary; you can leave at any time.
Who may be eligible?
This study is for adults aged 18 and over who have certain types of advanced cancer that have spread or come back. This includes specific types of breast cancer, ovarian cancer (including fallopian tube or primary peritoneal cancer), or prostate cancer.
For breast cancer, you should have had at least one previous chemotherapy treatment, and if your cancer is hormone-sensitive, you should have also had hormone therapy. For ovarian cancer, you must have had at least one platinum-based chemotherapy. If you have prostate cancer, you should be on ongoing hormone therapy and have had a specific type of hormone treatment, plus possibly one previous taxane chemotherapy.
There are also some general health requirements, such as being generally well enough for daily activities, having good organ function, and not having other serious medical conditions like active infections or certain heart problems. You also shouldn't have had any other experimental cancer treatments recently or have taken similar drugs to IMP1734 before. Women who could become pregnant and men must agree to use effective contraception during and for six months after 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 advanced breast, ovarian, or prostate cancer that fits the description?
- Are you generally well and able to manage daily activities?
- Do you have good kidney, liver, and blood cell function?
- Have you not had similar experimental cancer drugs very recently?
- Are you or your partner willing to use contraception if needed?
What does participation involve?
If you decide to take part, you'll receive the study drug, IMP1734. The study team will regularly check your health through blood tests, scans, and other examinations. They will watch for signs of how the drug is working and any side effects you might have. You’ll have scheduled visits to the hospital or clinic for these check-ups, and the frequency of these visits will depend on which part of the study you are in. The total time you'd be involved in the study isn't specified, but it would involve regular appointments and follow-up after your last dose.
Potential risks and benefits
Locations (53)
- The University of Arizona Cancer CenterVerified postcodeTucson, United States· Recruiting
- University of Arkansas Winthrop P. Rockefeller Cancer InstituteVerified postcodeLittle Rock, United States· Recruiting
- Hoag Health Center IrvineVerified postcodeIrvine, United States· Recruiting
- University California IrvineVerified postcodeIrvine, United States· Withdrawn
- Sharp Memorial HospitalVerified postcodeSan Diego, United States· Withdrawn
- University of California San Francisco (UCSF)Verified postcodeSan Francisco, United States· Withdrawn
- Sarah Cannon Research Institute Health OneVerified postcodeDenver, United States· Recruiting
- Smilow Cancer Hospital at Yale New HavenVerified postcodeNew Haven, United States· Recruiting
- Advent Health Research InstituteVerified postcodeCelebration, United States· Recruiting
- Sylvester Comprehensive Cancer CenterVerified postcodeMiami, United States· Recruiting
- University of Michigan Rogel Cancer CenterVerified postcodeAnn Arbor, United States· Recruiting
- Karmanos Cancer InstituteVerified postcodeDetroit, United States· Recruiting
Common questions
What is a 'first-in-human' study?
It means this is one of the very first times this new drug is being given to people to see if it's safe and how it works.
What kind of cancer is this study for?
It's for people with advanced solid tumours, specifically certain types of breast, ovarian, or prostate cancer that have spread or come back.
What is IMP1734?
It’s a new medicine being tested. It belongs to a group of drugs that target a specific protein in cancer cells, aiming to stop their growth.
Will I definitely get the new drug?
Yes, if you join this study, everyone receives the new drug IMP1734, as it's testing the drug itself, not comparing it to a dummy drug.
How long will I be in the study?
The precise duration isn't stated, but it involves regular check-ups and monitoring for a period, followed by observation after your last dose.
How to find out more
Nicola Lynch
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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