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

A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3084 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Advanced Malignancies Driven by the MAPK Pathway

This research is looking at a new medicine called DCC-3084 for people who have advanced cancers involving a specific growth signal in their body, known as the MAPK pathway. The study has two main parts. The first part focuses on finding the safest dose of DCC-3084 by itself and checking for any serious side effects. The second part will then look at how effective this medicine is at shrinking or stopping the cancer from growing, both when given on its own and when combined with other existing cancer treatments. This is a very early-stage trial, meaning it's one of the first times this medicine is being given to people. The aim is to learn more about how DCC-3084 works and if it could be a helpful treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Deciphera Pharmaceuticals Inc.

Enrolment target

Start

26 Jun 2025

Solid tumors driven by the MAPK Pathway

What is this study about?

This study, called a 'master protocol,' is exploring a new medicine named DCC-3084. It's designed for people who have advanced cancers where a specific cell pathway, known as the MAPK pathway, is driving the cancer's growth. Understanding this pathway is important because targeting it could help slow down or stop cancer. Think of it like a faulty switch inside your cells that tells them to grow too much – this medicine aims to flip that switch off.

The trial has two main stages. The first stage is about safety. Researchers will give different doses of DCC-3084 to a small number of people to see what side effects might occur and what the highest safe dose is. This part is crucial for making sure the treatment is as gentle as possible while still being effective. Once a safe dose is determined, the second stage will focus more on how well the medicine works against the cancer. This involves seeing if the cancer shrinks, stops growing, or even disappears in some cases.

DCC-3084 will be tested both on its own and in combination with other existing cancer medicines. Comparing these different approaches will help doctors understand the best way to use DCC-3084 if it proves to be a successful treatment. The overall goal is to gather important information about this new medicine to see if it can become a new option for patients with these specific types of cancer. This kind of early research is vital for finding new ways to fight cancer.

Key takeaways

This study tests a new cancer medicine, DCC-3084, for specific advanced cancers.
It aims to find a safe dose and see how well the medicine works.
The medicine targets a specific cancer growth signal called the MAPK pathway.
DCC-3084 will be tested alone and in combination with other treatments.
Participation involves regular clinic visits for monitoring and tests.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

The most important requirement is that you have advanced cancer that doctors believe is driven by something called the MAPK pathway. Your doctors would be able to tell you if your cancer fits this description based on special tests.

There might be other health checks or conditions that also need to be met, as is normal with any medical study, to make sure it's safe for you to participate and that the study results are clear. Your doctor or the study team will discuss all of these with you carefully.

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?
Has your doctor told you that you have an advanced cancer?
Has your doctor confirmed that your cancer is linked to the MAPK pathway?
Are you willing to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking the new medicine, DCC-3084. Depending on which part of the study you are in, you might take it alone or with other standard cancer treatments. This study is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.

Throughout the study, you would have regular visits to the clinic. These visits will involve various tests, such as blood tests, scans, and physical examinations, to check how you are responding to the treatment and to monitor for any side effects. The exact number and frequency of visits would be explained fully by the study team, but they are essential for safely monitoring your health and the medicine's effects. The total duration of your participation would depend on how your treatment is going, and you would continue as long as the medicine is helping and you are tolerating it well. There would also be follow-up appointments to check on your health even after you stop taking the study medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might gain access to a new medicine that isn't available elsewhere, which could help your specific type of advanced cancer. However, there's no guarantee the medicine will work for you, and it might not improve your condition. As with any medicine, DCC-3084 could cause side effects, some of which might be serious. The study team will monitor you closely for these effects and manage them as best they can. You are in control and have the right to withdraw from the study at any time, for any reason, without it affecting your 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 does 'advanced malignancies driven by the MAPK Pathway' mean?

This refers to cancers that have spread or are difficult to treat, and where a specific signal inside the cancer cells (called the MAPK pathway) is actively encouraging their growth.

What is DCC-3084?

DCC-3084 is a new medicine being tested. It's designed to specifically target the faulty MAPK pathway, aiming to stop the cancer cells from growing.

What does 'Phase 1/2 study' mean?

This means it's an early-stage study. Phase 1 focuses on finding a safe dose and checking for side effects, while Phase 2 looks at how well the medicine works against the cancer.

Will I know if I'm getting the new medicine or another treatment?

Yes, this is an 'open-label' study, which means both you and your medical team will know exactly which treatment you are receiving.

What is an 'Objective Response Rate (ORR)'?

ORR is a way doctors measure how well the treatment is working. It's the percentage of people whose cancer has shrunk or completely disappeared due to the medicine.