Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Study of the SHP2 Inhibitor BBP-398 (formerly known as IACS-15509) in combination with the KRAS-G12C Inhibitor Sotorasib in Patients with Advanced Solid Tumors and a KRAS-G12C Mutation

This research study is looking at a new treatment approach for advanced cancers, including a type of lung cancer, where the cancer cells have a specific genetic change called a KRAS-G12C mutation. The study will test a new medicine, called BBP-398, in combination with an existing medicine, sotorasib. Sotorasib is already used for some cancers with this mutation. Researchers want to see if combining these two drugs together is safe and if it can help stop cancer from growing. This is an early-stage study, meaning it's one of the first times this new combination is being tested in people. It aims to understand how the new drug works in the body and if it has any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Navire Pharma Inc.

Enrolment target

Start

12 Jan 2023

Advanced or metastatic solid tumors with a KRAS-G12C mutation Advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS-G12C mutation and who are KRAS-G12Ci naïve

What is this study about?

This study is about finding new ways to treat advanced cancers that have a specific genetic change in their cells, known as a KRAS-G12C mutation. This mutation can make cancer cells grow and spread more easily. This study is specially looking at cancers that have spread to other parts of the body (metastatic) or are hard to treat.

The researchers are testing a new medicine called BBP-398. They're giving it alongside another medicine called sotorasib, which is already used to treat some cancers with the KRAS-G12C mutation. The main idea is to see if using these two medicines together could be more effective than using sotorasib alone. This is an early-stage study, so the main goals are to check if the combination is safe, how the body handles the new medicine, and if it starts to show any signs of helping people.

Finding new treatments for advanced cancers with specific genetic changes is really important. If this combination treatment proves to be safe and promising, it could lead to better options for patients in the future. The study aims to gather important information that will help doctors understand if this new approach could eventually become a standard treatment.

Key takeaways

This study is for adults with advanced cancers that have a specific KRAS-G12C gene mutation.
It's testing a new combination of two medicines: BBP-398 (new) and sotorasib (existing).
The main goals are to check the combination's safety and how the body handles the new medicine.
Participants will have regular medical check-ups and close monitoring.
Participation is voluntary, and you can leave the study at any time.
This is an early-stage study, so benefits are not guaranteed.

Who may be eligible?

This study is looking for adults aged 18 or older, both men and women. To join, you must have advanced cancer that has spread or is hard to treat, and your cancer cells must have a specific genetic change called a KRAS-G12C mutation. This includes people with a type of lung cancer called non-small cell lung cancer (NSCLC) if it also has this specific KRAS-G12C mutation.

Importantly, if you have non-small cell lung cancer, you should not have received treatment with a KRAS-G12C inhibitor medicine (like sotorasib) before. This allows the researchers to see how the new combination works in people who haven't had this specific type of medicine yet. The study team will check your medical history and do some tests to make sure you meet all the requirements.

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 18 years old or older?
Do you have advanced or spread cancer?
Does your cancer have a KRAS-G12C gene mutation (your doctor can confirm this)?
If you have lung cancer (non-small cell), have you *never* taken a KRAS-G12C inhibitor medicine before?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for medical check-ups, blood tests, and other assessments. You would be given the study medicines (BBP-398 and sotorasib) as prescribed by the study doctors. These are usually taken by mouth or given as infusions. The doctors would closely monitor your health, how you're feeling, and any side effects you might experience. You would continue treatment for as long as it is safe and beneficial for you, or until the study doctor decides to stop it. The total time you spend in the study, including follow-up after stopping treatment, will be explained by the study team, but typically involves several months of active treatment and follow-up.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment combination that is not yet widely available, and close monitoring by medical experts. However, there are also potential risks, including side effects from the study drugs, which could be mild or serious. The new medicine, BBP-398, is being tested for the first time in combination, so not all side effects are fully known. You would be informed of all known risks before deciding to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (7)

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

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Unverified
Netherlands
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Unverified
Spain
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Unverified
France
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Unverified
Italy
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Unverified
Belgium
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Unverified
Denmark
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Unverified
Greece

Common questions

What is a 'KRAS-G12C mutation'?

It's a specific change in the genes of some cancer cells. This change can make the cancer grow more actively. This study is for people whose cancer has this particular genetic change.

What does 'advanced solid tumors' mean?

This means cancers that have spread from where they started to other parts of the body, or cancers that are difficult to treat with current standard therapies.

What is the study 'phase'?

This is a Phase 1 study. This means it's an early-stage study primarily focused on checking the safety of the new medicine combination and how your body handles it. It's not mainly about how well it treats the cancer yet, though that is also monitored.

What are BBP-398 and sotorasib?

BBP-398 is a new experimental medicine. Sotorasib is a medicine already available for some cancers with the KRAS-G12C mutation. The study is testing them together.

Will I receive a placebo?

No, in this study, all participants will receive the active study drugs (BBP-398 and sotorasib). There is no placebo group.