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RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

This study is looking at a new drug called GDC-7035 for people who have advanced solid tumours. This includes cancers that have spread to other parts of the body. The study is specifically for tumours that have a certain genetic error, known as a KRAS G12D mutation. This type of genetic change can make cancer grow and spread. The main goals are to find out if the new drug is safe to use, how your body processes it, and if it shows any signs of shrinking tumours. Researchers will test the drug on its own and also in combination with other anti-cancer treatments. This is the first time this drug is being tested in humans, and it's being done in different hospitals, starting with small doses and gradually increasing them.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Genentech, Inc.
Enrolment target
410
Start
14 Nov 2024
Estimated completion
31 May 2028

What is this study about?

This research study is focused on a new medicine called GDC-7035. It's being tested for people who have advanced solid tumours, which means their cancer may have grown or spread. A key part of this study is that it's specifically for those whose cancer has a particular change in its genes, known as a KRAS G12D mutation. This genetic change is important because it can affect how cancer cells grow and behave, and researchers are hoping that GDC-7035 might work by targeting this specific change.

The main aim of this study is to carefully look at how safe GDC-7035 is when given to people. Because it's a new drug, it's very important to understand any side effects it might cause. The study will also explore how the body handles the drug – how much of it gets absorbed, how long it stays in the body, and how it's eventually removed. This information is called pharmacokinetics and helps doctors understand the best way to give the drug.

Finally, the study will also check to see if GDC-7035 shows any early signs of helping to treat the cancer. This means looking to see if tumours shrink or if the cancer stops growing. The researchers will be trying the drug on its own first, and then in combination with other cancer treatments, to see if it works better when used with other medicines. This is an early-stage study, meaning it's one of the first times this drug is being tested in people.

Key takeaways

  • This study is testing a brand new drug, GDC-7035, for advanced solid tumours.
  • It's only for cancers with a specific genetic change called KRAS G12D.
  • The main goals are to check the drug's safety, how it works in the body, and if it helps treat cancer.
  • The drug will be tested on its own and with other cancer treatments.
  • This is an early-stage study (Phase I/II) to learn about the drug in people.

Who may be eligible?

To join this study, you must have a solid tumour that has spread or is advanced, and importantly, your tumour must have a specific genetic change called a KRAS G12D mutation. Your doctor can often test for this. You need to be at least 18 years old, and the study is open to both men and women.

There are certain health conditions that would prevent you from taking part. For example, if you have problems absorbing food and medicines properly, or if your cancer has spread to your brain in an active way. Serious heart or liver problems would also mean you couldn't join. If you are able to have children or father them, you would need to agree to use effective contraception during the study.

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. Do you have an advanced or metastatic solid tumour?
  2. Has your tumour been tested for a KRAS G12D genetic mutation?
  3. Are you 18 years of age or older?
  4. Do you have any active brain metastases (cancer spread to the brain)?
  5. Do you have any serious heart or liver problems?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for checks and tests. You would receive the study drug, GDC-7035, and doctors would closely monitor how you react to it. This would include blood tests to check drug levels and your overall health, as well as scans to see how your tumour is responding. The study will start with lower doses, slowly increasing them while ensuring your safety. You would have follow-up appointments after stopping the treatment to monitor your health. The total duration of your participation would depend on how your body responds to the treatment and the stage of the study you are in.

Potential risks and benefits

Potential benefits of joining include gaining early access to a new treatment that might help your specific type of cancer, especially if standard treatments haven't worked or aren't suitable. However, as with any new drug, there are potential risks, and GDC-7035 may cause side effects that are currently unknown. Your medical team will monitor you closely for any adverse reactions. It is very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UC San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States· Recruiting
  • Sarah Cannon Research Institute at HealthONE
    Verified postcode
    Denver, United States· Recruiting
  • Yale Cancer Center
    Verified postcode
    New Haven, United States· Recruiting
  • Florida Cancer Specialist-Lake Mary
    Verified postcode
    Lake Mary, United States· Completed
  • University of Illinois
    Verified postcode
    Chicago, United States· Recruiting
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • START - Midwest - EDOS
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Montefiore Einstein Cancer Center
    Verified postcode
    The Bronx, United States· Recruiting
  • Mary Crowley Medical Research Center
    Verified postcode
    Dallas, United States· Recruiting
  • Abramson Cancer Center;Univ of Pennsylvania
    Verified postcode
    Philadelphia, United States· Recruiting
  • SCRI Oncology Partners
    Verified postcode
    Nashville, United States· Recruiting
  • O'Quinn Medical Tower at McNair Campus
    Verified postcode
    Houston, United States· Recruiting

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas, unlike some other types of cancer. It can be found in many parts of the body.

What does 'KRAS G12D mutation' mean?

This is a specific change or 'error' in a gene called KRAS within your cancer cells. This change can make the cancer grow, and this study aims to see if the new drug can target this specific error.

What is a 'Phase I' study?

Phase I studies are the first time a new drug is tested in people. The main goal is to check if it's safe and to find the right dose, rather than focusing primarily on how well it treats the disease.

Will I get the new drug or a placebo?

In this specific study, everyone who participates will receive the active study drug, GDC-7035, either on its own or in combination with other treatments. No one will receive a placebo (dummy treatment).

What are 'pharmacokinetics'?

This refers to what your body does to the drug – how it absorbs it, distributes it, breaks it down, and removes it. It helps doctors understand the best way to give the medicine.

How to find out more

Reference Study ID Number: GO45416 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 Safety, Pharmacokinetics, and Activity o…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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