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RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)

This study is testing a new medicine called RO7673396 for people with advanced cancers that have a specific gene alteration known as a RAS mutation. The main goals are to find out if the drug is safe to use and what side effects it might cause. We'll also learn how the drug acts in the body. Initially, we will test different doses to find the safest and most effective amount. Once we find that, we'll give it to more people to see if it can help shrink their tumors. This is a Phase 1 study, meaning it's one of the first times this new drug is being tested in people.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Hoffmann-La Roche
Enrolment target
405
Start
30 Apr 2025
Estimated completion
25 May 2029

What is this study about?

This research study is about a new investigational drug, RO7673396, designed to treat advanced cancers. These are cancers that have spread or come back after treatment. What makes this study special is that it's focused on cancers that have a particular change in their genes, called a RAS mutation. Many cancers have this type of mutation, and researchers hope this new drug might specifically target these changed cells.

The main purpose of this study is to understand if RO7673396 is safe for people to take and what side effects it might cause. Doctors will also be looking at how the drug behaves in the body – for example, how much of it reaches the cancer cells and how long it stays in the body. We call this 'pharmacokinetics'. Once we understand the safety and how the drug works, we'll try to find the best dose.

After finding a suitable dose, the study will expand to see if the drug can help reduce the size of tumors or stop them from growing. This part of the study is called 'preliminary clinical activity'. This is an early-stage study, meaning it's one of the first times this drug is being tested in people. It's a key step in developing new treatments for cancer.

Key takeaways

  • This study is for adults with advanced cancers that have a specific gene change called a RAS mutation.
  • It's testing a new drug, RO7673396, to see if it's safe and if it can help fight cancer.
  • Participation involves regular visits, checks for side effects, and monitoring how the drug affects your body.
  • There's no guarantee the drug will work, and it may have side effects.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you would need to be an adult (18 or older) with a confirmed diagnosis of advanced cancer that has spread or returned. Importantly, your cancer must have a specific gene change called a RAS mutation. Your cancer also needs to be measurable, meaning doctors can track its size.

You should generally be well enough to take part in a study like this, meaning you can mostly go about your daily activities. You'd also need certain blood test results to show your organs are working properly. Some conditions might prevent you from joining. For example, if you're taking part in another drug trial, have severe allergies to the study drug's ingredients, or have serious gut problems that might stop the drug from being absorbed properly.

Also, if you've had major surgery recently, or if your cancer has spread to your brain in an uncontrolled way, you might not be able to participate. You shouldn't have active, recurring fluid build-up around your lungs or heart, or severe liver disease. Your doctor will review all your medical information carefully to see if this study is suitable for you.

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.

  1. Are you 18 years old or older?
  2. Do you have advanced cancer that has spread or returned?
  3. Has a specific gene change (RAS mutation) been found in your cancer?
  4. Are you generally well enough to go about your daily activities?
  5. Are you currently not taking part in another drug trial?
  6. Have you not had a major surgery recently (within the last 4 weeks)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new drug, RO7673396, as part of your treatment. The study has two main parts. In the first part, different groups of people will receive increasing doses of the drug to help doctors find the safest and most effective amount. In the second part, more people will receive that chosen dose to see if the drug helps fight their cancer.

Throughout the study, you'll have regular hospital visits. These visits will involve physical examinations, blood tests, and scans (like CT scans) to check how you're responding to the treatment and to monitor for any side effects. You'll also be asked questions about how you're feeling and any symptoms you might have. The total length of your participation will depend on how you respond to the treatment and what the doctors decide is best for your care, but you would have regular follow-up for a period after stopping the drug.

Potential risks and benefits

Taking part in a clinical trial like this could offer a potential benefit if the new drug, RO7673396, proves to be effective against your cancer when other treatments haven't worked. However, there's no guarantee the drug will help you, and it might not improve your condition. Like all medications, RO7673396 can cause side effects, which could be mild, moderate, or severe. The study aims to understand these side effects. You will be closely monitored by the study team, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States· Recruiting
  • University of Colorado - Anschutz Medical Campus - PPDS
    Verified postcode
    Aurora, United States· Recruiting
  • Smilow Cancer Hospital at Yale New Haven
    Verified postcode
    New Haven, United States· Recruiting
  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
    Verified postcode
    Sarasota, United States· Recruiting
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • South Texas Accelerated Research Therapeutics (START)
    Verified postcode
    San Antonio, United States· Recruiting
  • St Vincent's Hospital Sydney
    Verified postcode
    Darlinghurst, Australia· Recruiting
  • Peter MacCallum Cancer Center
    Verified postcode
    Parkville, Australia· Recruiting
  • Princess Margaret Hospital
    Verified postcode
    Toronto, Canada· Recruiting
  • Sun Yat-Sen University Cancer Center - Huangpu Campus
    Verified postcode
    Guangzhou, China· Recruiting
  • Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery
    Verified postcode
    Guangzhou, China· Recruiting
  • Fudan University Shanghai Cancer Center
    Verified postcode
    Shanghai, China· Recruiting

Common questions

What is a 'RAS mutation'?

A RAS mutation is a specific change in the genes of your cancer cells. Researchers believe this new drug might target these changed cells.

What does 'Phase 1' mean for this study?

Phase 1 means this is one of the first times this new drug is being tested in people. The main goals are to check its safety and find the right dose.

Will I get the actual drug, or a placebo?

Everyone in this study will receive the new drug, RO7673396. No one will receive a placebo (a dummy treatment).

How long will I be in the study?

The length of your participation will depend on your response to the treatment and your health, but you will have follow-up after treatment.

What are the main goals of this study?

The main goals are to find out if the drug is safe, what side effects it has, how it works in the body, and if it can help shrink tumors.

How to find out more

Reference Study ID Number: YO45758 https://forpatients.roche.com/

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Safety, Tolerability, Pharmacokineti…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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