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

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

This research study is looking at a new treatment called RP1, both on its own and when given together with an existing cancer drug called Opdivo (nivolumab). The study is for adult patients who have solid tumors, which are common types of cancer that form solid lumps. The main goals are to find out if RP1 is safe, what side effects it might cause, and to see if it can make tumors shrink. This is an early-stage trial, meaning it's one of the first times this treatment is being studied in people. Researchers will carefully monitor participants for any changes in their health and the size of their tumors to understand how well the treatment works and if it's well-tolerated.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Replimune Group Inc.

Enrolment target

Start

27 Sep 2024

Solid tumors

What is this study about?

This clinical trial is designed to investigate a new treatment called RP1, which is being tested in adults with various types of solid tumors. Solid tumors are cancers that form a mass, like those found in the breast, lung, or bowel. The study is divided into two main parts: Phase 1 and Phase 2. In Phase 1, the main focus is on safety. Researchers want to find the right dose of RP1 that can be given safely, both alone and when combined with an existing cancer medicine called nivolumab (brand name Opdivo). They will be closely watching for any side effects and how the body reacts to the treatment.

Once a safe dose is identified, the study moves into Phase 2. Here, the focus shifts to whether the treatment is effective in shrinking tumors. Researchers will measure how many patients' tumors shrink or stop growing after receiving RP1, either alone or with Opdivo. They will also continue to monitor for safety, checking for any side effects and the overall health of the patients. The study uses special guidelines to measure tumor changes and assess side effects.

The overall aim of this research is to see if RP1 could be a helpful new treatment option for people with solid tumors. By carefully studying its safety and effectiveness, doctors hope to gain a better understanding of how it works and whether it could improve outcomes for patients in the future.

Key takeaways

This study is testing a new cancer treatment (RP1) for adult patients with solid tumors.
It's an early-stage study focused on safety, side effects, and if tumors shrink.
RP1 is given alone or with an existing medicine called Opdivo.
Participants will have regular check-ups, blood tests, and scans.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for adults aged 18 years and older. Both men and women can take part. To be considered for the study, you must have been diagnosed with a solid tumor, which is a type of cancer that forms a lump or mass.

There will be other, more detailed criteria that your doctor will need to check to make sure the study is right for you. These criteria are put in place to ensure patient safety and to help the researchers get clear results. For example, your overall health, any other medical conditions you have, and previous treatments will be important factors.

It's very important to talk with your doctor if you're interested in this study. They can explain all the requirements and help you understand if you meet the specific criteria to participate.

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 tumor?
Are you comfortable with regular hospital visits and medical tests?
Are you able to understand and sign an informed consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study treatment, RP1, either on its own or together with Opdivo. The treatment involves a course of injections. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how your tumor is responding to the treatment. These visits are very important for the research team to gather all the necessary information. The exact number of visits, tests, and the total length of time you'd be involved in the study would depend on which part of the trial you're in and your individual response to the treatment. You would also have follow-up visits even after you stop taking the study treatment. All these details would be fully explained by the study team before you make any decisions.

Potential risks and benefits

Participating in a clinical trial may offer some potential benefits, such as access to a new treatment before it's widely available, and close monitoring by a medical team. However, there are also potential risks, including side effects from the treatment, which could range from mild to severe. As this is an early-stage study, not all risks or benefits are fully known yet. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
France
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Unverified
Spain

Common questions

What is a 'solid tumor'?

A solid tumor is a type of cancer that forms a mass or lump, unlike blood cancers like leukemia.

What is RP1?

RP1 is a new treatment being tested in this study. Researchers want to see how safe and effective it is for solid tumors.

What is Opdivo?

Opdivo (nivolumab) is an existing cancer medicine that works with your body's immune system. In this study, it's being tested alongside RP1.

Will I definitely get the new treatment?

Yes, all participants in this trial will receive the RP1 treatment, either by itself or with Opdivo. This study does not use a placebo.

How long will the study last for me?

The exact duration for each person can vary. Your study doctor will discuss the expected timeframe for visits and follow-up during the consent process.