Active not recruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

This research study is looking into a new medicine called GDC-6036 for adults who have advanced or spread cancer, including certain types of lung or bowel cancer. These cancers must also have a specific genetic change known as a KRAS G12C mutation. The main goals are to understand how safe the new medicine is, how it moves through the body, and if it shows early signs of shrinking cancer. Researchers will also test GDC-6036 on its own and in combination with other existing cancer treatments like Atezolizumab or Cetuximab. This is an early-stage study (Phase 1) designed to find the right dose and see if there are any promising effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Genentech, Inc.

Enrolment target

498

Start

29 Jul 2020

Estimated completion

31 Dec 2027

Non-Small Cell Lung Cancer Colorectal Cancer Advanced Solid Tumors

What is this study about?

This study is exploring a new treatment called GDC-6036 for certain advanced cancers. Cancer often develops because of changes in our genes. In this study, we're focusing on cancers that have a specific change in a gene called KRAS, known as a G12C mutation. This mutation can make cancer grow and spread.

The main aim is to understand if GDC-6036 is safe for people to take, what side effects it might cause, and how the body handles the medicine. We also want to see if the medicine has any positive effects on the cancer itself, such as slowing its growth or shrinking tumors. Sometimes, GDC-6036 will be given by itself, and other times, it will be given alongside other cancer medicines that are already used, like Atezolizumab or Cetuximab. This helps researchers learn if combining treatments works better.

This is an early stage, or 'Phase 1', study. Early stage studies are important because they help us learn a lot about new medicines, for example, what dose works best and what potential benefits or side effects there might be, before it can be tested in larger groups of people. The information gathered from this study will help decide if GDC-6036 has the potential to become a new treatment option for people living with these specific types of cancer.

Key takeaways

This study is for advanced cancers with a specific KRAS G12C gene change.
It tests a new medicine, GDC-6036, for safety and early signs of anti-cancer activity.
The medicine may be given alone or with other cancer treatments.
This is an early-stage (Phase 1) study.
Participation involves regular hospital visits for monitoring and assessments.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, your doctor would need to confirm that you have an advanced or spreading solid tumor, like lung or bowel cancer, and that tests show your cancer has a specific genetic change called a KRAS G12C mutation. You also need to be at least 18 years old. If you are able to have children, you would need to agree to use effective birth control throughout the study and for a period afterwards.

There are certain reasons why someone might not be able to join. For instance, if you have active cancer that has spread to your brain, or if you have serious heart or liver problems, you might not be eligible. If you have conditions that make it hard for your body to absorb medicines properly, you also might not be able to take part.

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.

Do you have advanced or spreading cancer?
Has your doctor confirmed your cancer has the KRAS G12C genetic change?
Are you at least 18 years old?
Do you have any serious heart, brain, or liver problems?
Do you have issues absorbing medicines properly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, GDC-6036, which might sometimes be given with other approved cancer treatments. You will have regular visits to the clinic for medical checks, blood tests, and scans to monitor your health and how the treatment is working. Doctors and nurses will explain how often these visits are needed and what each visit involves. The study will also track any side effects you experience. After you stop taking the study medicine, you'll have follow-up appointments to check on your health. The total time you'd be involved in the study, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Participating in a study like this may offer potential benefits, such as access to a new treatment before it's widely available, and you would be closely monitored by medical professionals. However, there are also potential risks; the new medicine might cause side effects, some of which could be serious or unexpected. The treatment might not help your cancer, or it could even worsen your condition. It's important to remember that joining a study is always your choice, and you are free to withdraw at any time for any reason, without affecting your usual medical care.

Locations (64)

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

City of Hope Comprehensive Cancer Center
Verified postcode
Duarte, United States
UCSD Moores Cancer Center
Verified postcode
La Jolla, United States
Chao Family Comprehensive Cancer Center UCI
Verified postcode
Orange, United States
Yale Cancer Center
Verified postcode
New Haven, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
University of Oklahoma
Verified postcode
Oklahoma City, United States
Abramson Cancer Center
Verified postcode
Philadelphia, United States
UPMC - Hillman Cancer Center
Verified postcode
Pittsburgh, United States
St Vincent's Hospital Sydney
Verified postcode
Darlinghurst, Australia
Slade Health Inward goods
Verified postcode
Mount Kuring-Gai, Australia
Peter MacCallum Cancer Center
Verified postcode
Melbourne, Australia
Alfred Health
Verified postcode
Melbourne, Australia

Common questions

What is a 'KRAS G12C mutation'?

It's a specific change in one of your genes that can make cancer cells grow. This study is for people whose cancer has this particular genetic change.

What does 'advanced or metastatic solid tumor' mean?

This means cancer that has grown beyond its original location or has spread to other parts of the body.

What is a 'Phase 1' study?

Phase 1 is an early stage of testing a new medicine. It mainly focuses on finding a safe dose and understanding any side effects, rather than how well it cures the disease.

Will I definitely get the new medicine?

Yes, everyone in this study will receive the new medicine, GDC-6036, either on its own or with other treatments.

What kind of commitment is needed if I join?

You'll need to attend regular clinic visits for check-ups, blood tests, and scans. The study team will give you a detailed schedule.