RecruitingPHASE1INTERVENTIONAL

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

This research study, called MK-1084-001, is exploring a new medicine named Calderasib. It's being tested on its own and in combination with other existing cancer treatments like Pembrolizumab, carboplatin, and others. The study focuses on people with advanced solid tumours that have a particular gene mutation called KRAS G12C. This is a "Phase 1" study, which means the main goals are to check how safe the new drug is, how it moves through the body, and if it shows any early signs of working. It aims to understand if Calderasib could be a helpful treatment option for specific advanced cancers that have this genetic change.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

830

Start

17 Dec 2021

Estimated completion

25 Feb 2030

Advanced Solid Tumors

What is this study about?

This study is looking into a new medication called Calderasib. It's designed to treat advanced solid tumours, which are cancers that have grown or spread in different parts of the body. The study is particularly interested in cancers that have a specific change in their genes, known as the KRAS G12C mutation. Researchers believe this particular gene change might make the cancer respond differently to certain treatments.

You might be offered Calderasib on its own, or in combination with other cancer medicines you might already know, such as Pembrolizumab, carboplatin, or others. The main aim of this study is to see if Calderasib is safe for people to take and how well their bodies handle it. It also wants to find out if the drug has a positive effect on the cancer. Since this is an early-stage study (Phase 1), it's the first step in understanding if Calderasib could become a new treatment option for people with this type of cancer.

Finding new ways to treat advanced cancers with specific gene mutations like KRAS G12C is very important. This research helps us learn more about tailoring treatments to individual cancers, which could lead to better outcomes for patients in the future. By participating, you could help doctors understand more about this new medicine.

Key takeaways

This study is testing a new drug for advanced cancers with a specific gene change (KRAS G12C).
It's an early-stage study (Phase 1) focused on safety and finding the best dose.
The new drug, Calderasib, may be given alone or with other cancer treatments.
Participation involves regular hospital visits for checks and tests.
There are potential benefits like accessing new treatment, but also risks of side effects.
You can stop participating at any time.

Who may be eligible?

To join this study, everyone must have a solid tumour that can be measured by doctors.

Most participants will need to have a specific change in their cancer's genes called a KRAS G12C mutation. Depending on which group of the study you might join, you may need to have had at least one previous line of treatment for your cancer that didn't work as well as hoped. For some lung cancers (non-small cell lung cancer), you might be able to join if you haven't had treatment yet, but your cancer must show the KRAS G12C gene change and a certain level of another marker called PD-L1.

All participants must be over 18 years old and have good organ function (meaning your kidneys, liver, and other major organs are working well). For women, you must not be pregnant or breastfeeding and will need to use specific contraception. Men also have contraception requirements and should not donate sperm.

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 I have a type of cancer that doctors can accurately measure?
Has my doctor confirmed that my cancer has a KRAS G12C gene mutation?
Are my major organs (like liver, kidneys) working well?
Am I 18 years old or older?
If I am a woman, am I not pregnant or breastfeeding, and willing to use birth control?
If I am a man, am I willing to use birth control and not donate sperm during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, Calderasib, which might be on its own or with other medicines. You'll have regular appointments at the hospital where the study team will monitor your health carefully. This will involve physical examinations, blood tests, and scans (like X-rays or CT scans) to check how the treatment is affecting your cancer and your body. The team will also ask you how you are feeling and if you are experiencing any side effects.

The specific number of visits and tests will depend on which part of the study you are in and how you respond to the treatment. You'll be given detailed information about your exact schedule. The study will continue as long as the treatment is helping you and you are not experiencing severe side effects. There might be some follow-up appointments after you stop taking the study medication.

Potential risks and benefits

Taking part in a clinical trial has both potential benefits and risks. One potential benefit is that you might gain access to a new treatment, Calderasib, that isn't yet widely available. This treatment might help slow down or shrink your cancer. However, there's no guarantee that the treatment will work for you, and it's also possible it might not be better than standard treatments. As with all medications, there's a risk of side effects. These can range from mild to severe, and the study team will monitor you closely for any issues. They will explain all the known and possible side effects to you before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (75)

Moffitt Cancer Center ( Site 0261)
Verified postcode
Tampa, United States· Recruiting
START Midwest ( Site 0267)
Verified postcode
Grand Rapids, United States· Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
Verified postcode
Hackensack, United States· Recruiting
Laura and Isaac Perlmutter Cancer Center ( Site 0270)
Verified postcode
New York, United States· Completed
NEXT Virginia ( Site 0271)
Verified postcode
Fairfax, United States· Recruiting
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
Verified postcode
Milwaukee, United States· Recruiting
Instituto Alexander Fleming ( Site 0434)
City only
Ciudad Autónoma de Buenos Aires, Argentina· Recruiting
Sanatorio Parque ( Site 0456)
Verified postcode
Rosario, Argentina· Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)
Verified postcode
La Rioja, Argentina· Recruiting
Chris O'Brien Lifehouse ( Site 0002)
Verified postcode
Camperdown, Australia· Recruiting
Liverpool Hospital-Medical Oncology ( Site 0001)
Verified postcode
Liverpool, Australia· Recruiting
Westmead Hospital ( Site 0006)
Verified postcode
Westmead, Australia· Recruiting

Common questions

What is a 'KRAS G12C mutation'?

It's a specific change in your cancer's genetic code (DNA) that doctors can sometimes find. This change can affect how your cancer grows and responds to treatments.

What does 'advanced solid tumours' mean?

This refers to cancers that have grown beyond their original location, sometimes spreading to other parts of the body. They are not usually treatable with surgery alone.

Is Calderasib a type of chemotherapy?

Calderasib is a targeted therapy, which is different from traditional chemotherapy. It's designed to specifically attack cancer cells with the KRAS G12C mutation, often leading to fewer side effects than general chemotherapy.

What does 'Phase 1' mean for a study?

Phase 1 is the first step in testing a new drug in humans. The main goal is to check how safe it is and find the right dose, rather than primarily proving how well it works.

Will I definitely receive the new drug if I join?

Yes, if you meet all the eligibility criteria and join this study, you will receive Calderasib, either on its own or with other existing cancer treatments.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

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