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

A Phase 1 study to look at RP-6306 in combination with FOLFIRI as a treatment for Advanced Solid Tumours

This study is looking at a new treatment called RP-6306 when given together with a common chemotherapy treatment called FOLFIRI. It's for adults who have advanced solid tumours, which means cancer that has grown or spread. This is a very early study, called a Phase 1 study, which means it’s one of the first times this new combination is being tested in people. The main aim is to see if the new combination is safe and what doses can be given without causing too many problems. Researchers will also be looking to see if the treatment has any positive effects on the cancer. Even though it's an early study, it's an important step in finding new ways to treat cancer. Both men and women aged 18 and over can potentially take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Repare Therapeutics USA Inc.

Enrolment target

Start

24 Apr 2024

Advanced solid tumours

What is this study about?

This research study is focused on people who have advanced solid tumours. "Advanced" means that the cancer has either grown significantly or has spread to other parts of the body. "Solid tumours" refer to cancers that form a lump or mass, like breast cancer, lung cancer, or bowel cancer, as opposed to blood cancers like leukaemia.

The study is testing a new treatment called RP-6306 alongside a standard chemotherapy treatment called FOLFIRI. FOLFIRI is already a well-known and commonly used chemotherapy combination for many types of advanced cancers. The aim here is to see if adding RP-6306 to FOLFIRI can make the treatment more effective or help in ways that FOLFIRI alone doesn't.

This is a Phase 1 study, which means it's one of the very first times this specific combination is being tested in people. The main goals of a Phase 1 study are to find out if a new treatment is safe, what the best dose is, and what side effects it might cause. Researchers will carefully watch participants to understand how their bodies react to RP-6306 when given with FOLFIRI. While finding effective ways to treat the cancer is a hope, the primary focus at this stage is safety.

Key takeaways

This is an early-stage study (Phase 1) for advanced solid tumours.
It combines a new drug (RP-6306) with standard chemotherapy (FOLFIRI).
The main goals are to check safety and find the right dose of the new combination.
Participation is open to adults aged 18 and over.
You'll have close medical monitoring throughout the study.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 and older. There is no upper age limit, so older adults can also be considered.

To be eligible, you must have advanced solid tumours. This means your cancer has either spread or grown significantly and standard treatments may no longer be working as well as hoped. Both men and women can take part.

There will be other detailed medical criteria that a doctor will need to check to make sure the study is a good fit for you and safe. For example, they will look at your overall health, any other medical conditions you have, and if you've had certain treatments recently.

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 diagnosis of advanced solid tumour cancer?
Are you able to attend regular hospital visits?
Are you available for the full duration of the study activities?
Are you open to trying a new treatment combination?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication (RP-6306) along with the FOLFIRI chemotherapy. Your participation would involve regular visits to the clinic or hospital. These visits would include physical examinations, blood tests, and possibly scans to monitor your health and how the treatment might be affecting your cancer. You would be closely monitored for any side effects.

The length of your participation would depend on how your body responds to the treatment and your general health. You would continue treatment as long as it is safe and you are tolerating it well, and it appears to be helping. There would also be a follow-up period after you stop treatment to continue monitoring your health and any long-term effects.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that aren't yet widely available, and you would be closely monitored by medical professionals. However, as this is an early-stage study, the benefits are not guaranteed. There's a risk of experiencing side effects from the treatments, some of which could be severe, as the full range of side effects for this combination isn't yet known. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What does 'advanced solid tumours' mean?

It means a cancer that forms a mass or lump, like breast or lung cancer, which has grown or spread in the body.

What is FOLFIRI?

FOLFIRI is a standard combination of chemotherapy drugs already used to treat many types of advanced cancer.

Is RP-6306 a new drug?

Yes, RP-6306 is a new investigational drug being tested in combination with FOLFIRI in this study.

Will I definitely get the new drug?

Yes, in this study, all participants will receive the investigational drug RP-6306 along with FOLFIRI.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.