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

A Phase 1/2, First in Human Study of DCC-3116 as Monotherapy and in Combination With RAS/MAPK Pathway Inhibitors in Patients With Advanced or Metastatic Solid Tumors With RAS/MAPK Pathway Mutations

This study is looking into a new experimental medicine called DCC-3116, for adults aged 18 and over who have advanced or metastatic cancer. This includes non-small cell lung cancer and other solid tumours, which means cancers that form a lump. This is a "first-in-human" study, which means it's among the first times this drug is being given to people. Researchers want to find out if DCC-3116 is safe and if it helps shrink tumours, both when given alone and in combination with other existing cancer medicines. The main aim is to see how many people's tumours shrink or disappear, and to understand any side effects. This research could help develop new treatments for these types of cancer 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

11 Jan 2024

Non-Small Cell Lung Cancer Metastatic Solid Tumor Advanced Solid Tumor

What is this study about?

This research study is focused on a new investigational medication called DCC-3116. It's designed for people who have advanced cancer that has spread (metastatic) or is hard to treat. Specifically, it's looking at cancers that have certain changes in their cells, known as 'RAS/MAPK pathway mutations'. These changes can make cancer grow and spread.

The study has two main parts. In the first part, researchers will give small doses of DCC-3116 to a few people to make sure it's safe and to find the best dose. In the second part, they will give the chosen dose to more people, both on its own and combined with other cancer medications like LUMYKRAS. The main goal is to see if these treatments can make tumours shrink or stop growing.

The information gathered from this study is really important. It will help doctors understand if DCC-3116 could be a new and effective treatment option for people with these specific types of advanced cancers. By testing it alone and with other drugs, they can figure out the best way to use it to potentially improve patient outcomes.

Key takeaways

Tests a new medicine, DCC-3116, for advanced cancers.
Aims to check safety and effectiveness, alone and with other drugs.
For solid tumours, like non-small cell lung cancer, with specific genetic changes.
You'll take tablets and have regular check-ups, scans, and blood tests.
Early-stage research; potential benefits are not guaranteed, and side effects are possible.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women can take part.

You would need to have certain types of advanced solid tumours, which means cancers that form a lump, including non-small cell lung cancer, which have specific genetic changes called 'RAS/MAPK pathway mutations'. Your doctor would be able to confirm if your cancer has these particular changes.

There might be other health requirements or previous treatments you've had that could affect whether you can join, so your doctor will need to check your full medical history.

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 at least 18 years old?
Do you have an advanced solid tumour (like non-small cell lung cancer)?
Has your doctor confirmed your cancer has 'RAS/MAPK pathway mutations'?
Are you generally well enough to take part in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the experimental medicine, DCC-3116, which might be on its own or with another cancer drug called LUMYKRAS, in tablet form. The study will involve regular visits to the clinic so the doctors can carefully monitor your health. These visits will include checks on your general health, blood tests, and scans to see how your tumour is responding to the treatment.

The doctors will track any side effects you might experience and how the medicine affects your body over time. The total length of your participation would depend on how you respond to the treatment and the study's design. You would have regular check-ups to assess the treatment, and if you stop taking the study medication, you might still have follow-up visits.

Potential risks and benefits

Taking part in this study might mean you could be among the first to receive a new treatment that could help shrink your tumour or slow its growth. However, because this is an early-stage trial, the potential benefits are not guaranteed, and the medicine might not help everyone. As with all medicines, there is a risk of side effects, some of which could be serious or unexpected. Doctors will monitor you closely for any problems, and you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
Italy
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Unverified
Spain
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Unverified
France

Common questions

What does 'Phase 1/2' mean?

This means it’s an early-stage study. Phase 1 checks if the new medicine is safe and finds the right dose. Phase 2 then sees if it works against the cancer.

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. It's the most common type of cancer, unlike blood cancers like leukaemia.

What are 'RAS/MAPK pathway mutations'?

These are specific changes in your cancer cells that can make the cancer grow. This study is for people whose cancer has these particular changes.

Will I get a placebo (dummy medicine)?

No, this study does not mention a placebo. You would either receive DCC-3116 alone or DCC-3116 with another active cancer drug.

What does 'Objective Response Rate' mean?

This is a way for doctors to measure how well the treatment is working. It means seeing if your tumour shrinks or completely disappears.