Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants with Advanced Solid Tumors

This is an early-stage medical study, often called a 'Phase 1' trial, looking into a new unproven medicine named RP-1664. It's for adults who have advanced solid tumours which means the cancer has spread and current treatments haven't worked or are no longer suitable. The main goal is to see if RP-1664 is safe and what side effects it might cause. We will also be looking at how the body handles the medicine and if there are any early hints that it might help shrink tumours. This research is crucial for understanding if RP-1664 could be a potential new treatment in the future. As it's a first-in-human study, there's a focus on careful monitoring.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Repare Therapeutics USA Inc.

Enrolment target

Start

16 Jul 2024

Advanced Solid Tumors

What is this study about?

This study is a very early step in checking a new potential medicine called RP-1664 for people living with advanced solid tumours. "Advanced solid tumours" means cancers that have spread from their original site in the body, like bowel cancer, lung cancer, or breast cancer, when they are no longer responding to standard treatments. Because it's a 'Phase 1' study, it's the first time this specific medicine is being given to people. This means we don't yet know much about how it works in the human body, or what the side effects might be.

The main purpose of this study is to find out if RP-1664 is safe for people and what dose might be best. The research team will carefully watch for any side effects and see how the medicine moves through and is used by your body. They'll also look for any very early signs that the medicine might be helping to shrink the tumours or slow their growth.

While this study is primarily about safety and understanding the drug, any information we gather about RP-1664's effects on tumours is very important. This helps researchers decide if the medicine should be studied further in larger trials to see if it can become a new treatment option for cancer in the future. It's important to remember that because this is such an early study, it's not expected to cure cancer.

Key takeaways

Tests a new medicine (RP-1664) for advanced solid tumours.
First time the medicine is given to humans ('Phase 1' study).
Main goal is to check safety and find the right dose.
Will monitor for side effects and early signs of tumour response.
Participation involves regular hospital visits and tests.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. The study is open to both men and women.

In general, this study is for people who have advanced solid tumours. This means your cancer has spread, and other treatments haven't worked as well as hoped, or there are no other suitable treatment options available for you.

There will be other, more detailed criteria that the study doctors will check to make sure the study is safe and right for you. These might include things like your general health, how well your organs are working, and what other treatments you might have had recently. Your doctor will discuss all these with you.

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 solid tumours?
Have you discussed your cancer diagnosis and treatment history with your doctor?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, RP-1664. The dose and how often you take it will be decided by the study doctors, as they are trying to find the safest and most effective way to give the medicine. You will need to attend regular appointments at the hospital or clinic. During these visits, the study team will carry out various checks, such as blood tests, physical examinations, and scans (like CT or MRI scans) to monitor your health, how your body is handling the medicine, and to see if there are any changes in your tumour size. You will also be asked questions about how you are feeling and any side effects you might be experiencing. The total duration of your participation in the study will depend on how you respond to the treatment and your health, but you will be monitored closely throughout.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you would have access to a new medicine that isn't available outside of the study, and it might help your advanced cancer. However, as this is the first time this medicine is being given to humans, there's a risk of unknown side effects, and it might not help your cancer at all. The research team will monitor you very closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark

Common questions

What does 'Phase 1' mean?

Phase 1 means this is the very first time this new medicine is being tested in people. The main focus is on safety and finding the right dose.

What are 'advanced solid tumours'?

These are cancers that started in solid organs (like the lung, bowel, or breast) and have spread to other parts of the body.

Will I be cured by this medicine?

This early-stage study is not expected to cure cancer. Its main goal is to see if the medicine is safe and if it shows any early signs of benefit.

What kind of tests will I have?

You'll have regular checks like blood tests, physical exams, and scans to monitor your health and how the medicine affects your body and tumour.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your ongoing medical care.