Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Study of RP2 alone and in combination with PD1 Blockade in patients with solid tumours

This research is looking into a new treatment called RP2. Scientists want to understand if RP2 works well by itself, and also if it works better when given alongside another type of drug called a 'PD1 Blockade'. This study is for people who have been diagnosed with solid tumours, which are abnormal growths of tissue that can form in many parts of the body. Because this is a 'Phase I and Phase II' study, it means it's an early step in testing new medicines. The main goals are to check if the new treatment is safe for people, to find the right dose, and to see if it shows any promising signs of helping to treat the tumours. It's the first time this specific treatment is being given to human volunteers.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Replimune Group Inc.

Enrolment target

Start

08 May 2024

Solid tumors

What is this study about?

This study is a clinical trial, which is a type of research aiming to find new and better ways to prevent, detect, or treat diseases. In this particular study, researchers are focusing on a new treatment called RP2. They are keen to see how RP2 works when given on its own, and also how it performs when combined with another drug known as a PD1 Blockade. The goal is to see if this new approach could be an effective way to help people with solid tumours.

Solid tumours are a broad group of cancers that form a mass or lump. They can appear in many different places in the body. Finding new treatments for solid tumours is very important, and studies like this help scientists learn more about how to fight these conditions.

This is an 'integrated Phase I and Phase II' study. 'Phase I' means it's the very first time this new treatment is being given to people. The main aim here is to make sure the drug is safe and to find the best dose to use. If it seems safe and effective, the study then moves into 'Phase II' where more people receive the treatment to see if it has promising benefits against the tumour. This step-by-step approach is crucial to ensure that any new treatment is thoroughly tested before it can become widely available.

Key takeaways

This study is testing a new treatment called RP2 for solid tumours.
RP2 is being looked at both alone and with another drug (PD1 Blockade).
It's an early-stage study (Phase I and II), focusing on safety and initial effectiveness.
Participants must be 18 years or older and have a solid tumour.
Takes place in the UK for a general audience.
Your health would be closely monitored if you participate.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, which means people of all adult ages can be considered.

The study is open to both men and women. The main requirement is that you have a solid tumour.

Other specific medical details will be checked by the study doctors to make sure the trial is right and safe for you. This might include your general health, any other medical conditions you have, and treatments you've had in the past. These details help ensure the study is suitable for everyone involved.

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?
Have you been diagnosed with a solid tumour?
Are you able to attend regular appointments for treatment and check-ups?
Are you comfortable considering an experimental treatment?

Answer every question to see your result.

What does participation involve?

Taking part in a clinical study involves several steps. You would first have screening visits, where doctors would check your medical history, do physical exams, and run some tests (like blood tests or scans) to confirm you meet all the requirements. If you're eligible, you would then start receiving the study treatment, which is RP2 (either alone or with PD1 Blockade). This would involve regular visits to the clinic for treatments, check-ups, and more tests to monitor your health and how your body is responding to the treatment.

During the study, you'd be closely monitored for any side effects. The exact number of visits, tests, and how long you take the treatment will depend on the study plan, which the doctors will explain fully. After the treatment period, there will usually be a follow-up phase where doctors continue to monitor your health for a certain amount of time, even if you're no longer receiving the study drug. The total duration of your involvement could range from several months to potentially a year or more, depending on the study's design.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and helping others by contributing to medical knowledge. However, there are also potential risks, including side effects from the experimental drugs, or the treatment not working for you. Because this is an early-stage study, not all side effects or benefits are fully known. You would be closely monitored, and you have the right 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.

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Unverified
Spain

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a mass or lump of tissue. They can occur in many different parts of the body, unlike blood cancers. Examples include tumours in the breast, lung, or bowel.

What does 'Phase I and II' mean for a study?

This means it's an early-stage study. Phase I focuses on whether a new treatment is safe and finding the right dose. Phase II then checks if it shows any signs of working well for the condition, after safety has been established.

What is RP2?

RP2 is the name of a new treatment being tested in this study. It's an experimental drug, which means it's not yet approved for general use, and researchers are trying to understand how it works and if it can help treat solid tumours.

What is 'PD1 Blockade'?

PD1 Blockade refers to another type of drug that works with your immune system to help it fight cancer. In this study, RP2 is being tested both by itself and together with this kind of drug.

Can I stop participating in the study at any time?

Yes, absolutely. Your participation is completely voluntary, and you are free to withdraw from the study at any point, for any reason. This will not affect the medical care you receive.