Active not recruitingPHASE1INTERVENTIONAL

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations

Doctors are studying two medicines, Naporafenib and Trametinib, to see if they can help people with advanced cancers that have a specific genetic change called RAS Q61X. This trial is for people whose cancer has spread or is advanced, and who haven't responded to previous treatments or don't have other standard options. Researchers want to find out how well these medicines work, if they are safe, and how the body handles them. The study includes about 115 adults and some teenagers, aiming to understand if this new combination could be a potential treatment for this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Erasca, Inc.

Enrolment target

Start

17 Aug 2023

Estimated completion

01 Dec 2026

Advanced or Metastatic Solid Tumors

What is this study about?

This study, called SEACRAFT-1, is looking into a new treatment for certain advanced or widespread cancers. The treatment involves two medicines, Naporafenib and Trametinib, given together. Doctors are interested in people whose cancer has a very specific genetic change, which they call a "RAS Q61X mutation." This particular change in the cancer cells is important because these medicines are designed to target it.

The main goals of the study are to see how effective this combination of medicines is at shrinking or controlling the cancer, and to understand if it's safe for people to take. They also want to learn how the body takes in, processes, and gets rid of these medicines. This helps them work out the best way to give the drugs.

This is an early-stage study, meaning it's one of the first times these medicines are being used together in people with this specific type of cancer. It's open to adults and some teenagers aged 12 and older whose cancer has either spread, is too advanced for surgery, and who haven't responded to standard treatments or don't have other established options. Importantly, your cancer must have the RAS Q61X genetic change to be considered for this study.

Key takeaways

Tests new medicines for advanced cancer with a specific genetic change.
For adults and some teenagers whose cancer hasn't responded to other treatments.
Aims to check how well the drugs work and their safety.
Involves taking two medicines by mouth.
Requires regular clinic visits for monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 12 years old. Your cancer needs to be advanced or have spread, and you would have already tried other standard treatments without success, or there might not be any standard treatments available for your cancer. Your doctor might also consider you if you can't tolerate other treatments, or if you decide not to have them.

A key requirement is that your cancer must have a specific genetic change called "RAS Q61X." This will be confirmed by looking at a sample of your cancer tissue or blood. You also need to be generally well enough to take part, and be able to swallow tablets or capsules.

There are also reasons why you might not be able to join. For example, if you've already had similar types of cancer treatments, or if you have certain heart problems, eye conditions, or tummy issues that could affect the medicines. People with primary brain cancer are also not eligible, but if your cancer started elsewhere and then spread to your brain, you might still be considered if it's stable.

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.

I am at least 12 years old.
My cancer is advanced or has spread.
I have tried other cancer treatments, or there aren't any standard options for me, or I can't have them.
My cancer has been tested and confirmed to have the RAS Q61X genetic change.
I can swallow medicines by mouth.
I haven't taken similar types of cancer drugs in the past (like ERK, MEK, RAF, or RAS inhibitors).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be taking two medicines, Naporafenib and Trametinib. These are usually taken by mouth. You'll have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your cancer and how you're feeling. Doctors will keep a close eye on any side effects.

The study is 'open-label,' which means both you and your doctor will know which medicines you are receiving. The total duration of your participation will depend on how you respond to the treatment and the decisions made with your study doctor. You'll continue treatment as long as it's helping and the side effects are manageable. There will also be follow-up appointments after you stop taking the study medicines.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like access to new treatments before they are widely available, and you'll receive careful medical monitoring. However, it's also important to remember that these medicines are still being studied, so their full effects aren't completely known. You might experience side effects, some of which could be serious. The medicines might not work for your cancer, or they might not work as well as hoped. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

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

University of California, San Francisco
Verified postcode
San Francisco, United States
Yale Cancer Center
Verified postcode
New Haven, United States
Florida Cancer Specialists - Sarasota
Verified postcode
Sarasota, United States
Florida Cancer Specialists - St. Petersburg
Verified postcode
St. Petersburg, United States
Emory University School of Medicine
Verified postcode
Atlanta, United States
Henry Ford Health System
Verified postcode
Detroit, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Comprehensive Cancer Center of Nevada (CCCN)
Verified postcode
Las Vegas, United States
Oregon Health & Science University
Verified postcode
Portland, United States
SCRI Oncology Partners (formerly Tennessee Oncology)
Verified postcode
Nashville, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
Inova Schar Cancer Institute
Verified postcode
Fairfax, United States

Common questions

What is advanced or metastatic cancer?

Advanced cancer means it's progressed, and metastatic means it has spread from where it started to other parts of the body.

What is a RAS Q61X mutation?

This is a specific change in the genetic make-up of your cancer cells that the study medicines are targeting.

Are the study medicines tablets or injections?

Both Naporafenib and Trametinib are medicines you take by mouth, usually as tablets or capsules.

Will I know if I am receiving the actual treatment or a placebo?

This is an 'open-label' study, meaning you and your doctor will know that you are receiving the study medicines, not a placebo (dummy drug).

How long will I be in the study?

You will continue on the study as long as the treatment is helping you and you are managing any side effects well, as decided by your study doctor.