Study of JDQ443 and Ribociclib in Combination for Adult Patients with Advanced Solid Tumors with KRAS G12C Mutation

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced cancer that has a specific mutation called KRAS G12C. The study involves patients with different types of solid tumors, including those that are metastatic, meaning the cancer has spread to other parts of the body, or unresectable, meaning it cannot be removed with surgery. The main purpose of the study is to explore the safety and effectiveness of various treatment combinations.

The treatments being tested include a medication with the code name JDQ443, which is taken as a tablet. Other medications involved in the study are LEE011 (known as ribociclib), Mekinist (known as trametinib), and TMT212 (a form of trametinib dimethyl sulfoxide). Additionally, Cetuximab, which is given as an infusion into a vein, is also part of the study. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study is conducted in two phases. The first phase involves gradually increasing the dose of the medications to determine the safest and most effective dose. The second phase assesses how well the treatments work in controlling the cancer. Participants will take the medications as directed and attend regular check-ups to monitor their health and the cancer’s response to the treatment. The study aims to find the best treatment combinations for future use in patients with this specific genetic mutation.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history, physical examination, and laboratory tests. You must have a specific gene mutation called KRAS G12C and meet other criteria to participate.

3 treatment phase

During the treatment phase, you will receive the study medication. The main medication being tested is JDQ443, which is taken orally. You may also receive other medications in combination, such as LEE011, Mekinist, or Cetuximab, depending on your specific treatment plan.

The dosage and frequency of the medications will be determined by the study team and may vary based on the phase of the trial and your response to the treatment.

4 regular monitoring

Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to assess the tumor’s response.

You will be asked to report any side effects or changes in your health to the study team.

5 dose adjustment

If necessary, the study team may adjust your medication dose based on your tolerance and any side effects experienced. This is to ensure your safety and the effectiveness of the treatment.

6 end of treatment

At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the treatment. This may include additional tests and imaging studies.

You will be informed about the results and any further steps or follow-up care needed.

Who Can Join the Study?

Patients must be adults with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors. This means the cancer has spread or cannot be removed by surgery and has a specific genetic change called KRAS G12C.
For the dose escalation part of the study, patients should have already received standard treatment or be unable to receive it.
For Phase II of the study, patients with advanced non-small cell lung cancer must have received a platinum-based chemotherapy and a type of treatment called an immune checkpoint inhibitor, unless they were not eligible for these treatments.
For Phase II of the study, patients with advanced colorectal cancer must have received specific chemotherapy treatments, unless they were not eligible for these treatments.
All patients must have an ECOG performance status of 0 or 1. This is a scale that measures how well patients can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
All patients must have a part of their disease that can be biopsied, meaning a small sample can be taken for testing, and they must be suitable for this procedure according to their doctor’s guidelines.
Both male and female patients can participate.

Who Cannot Join the Study?

Patients who do not have a KRAS G12C mutant solid tumor. This means the specific type of cancer cell mutation must be present.
Patients whose cancer is not advanced. This refers to cancer that has spread to other parts of the body or cannot be removed by surgery.
Patients who are not adults. Only adult patients can participate.
Patients who are not able to understand or agree to the study requirements.
Patients who are part of a vulnerable population. This includes groups who may need special protection, like children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Cpbrxm Lzen Bnklsf	Lyon	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	24.10.2022
France	Not recruiting	24.10.2022
Germany	Not recruiting	24.10.2022
Italy	Not recruiting	24.10.2022
Spain	Not recruiting	24.10.2022

Trial locations

Investigated drugs:

JDQ443 is an experimental medication being tested in this clinical trial. It is designed to target a specific mutation in cancer cells known as KRAS G12C. This mutation is found in some advanced solid tumors, and the medication aims to block the activity of the mutated protein, potentially slowing down or stopping the growth of the cancer. The trial is exploring how safe and tolerable this medication is for patients, as well as its effectiveness in reducing tumor size or slowing tumor growth.

Investigated diseases:

KRAS G12C Mutant Solid Tumors – KRAS G12C mutant solid tumors are a type of cancer characterized by a specific mutation in the KRAS gene, which is involved in cell signaling pathways that control cell growth and division. This mutation leads to uncontrolled cell proliferation, resulting in tumor formation. These tumors can occur in various organs, including the lungs, colon, and pancreas. As the disease progresses, the tumors may grow larger and spread to other parts of the body, becoming metastatic. The progression of these tumors can lead to symptoms such as pain, weight loss, and fatigue, depending on the location and size of the tumors. The disease is often diagnosed at an advanced stage when the tumors are either metastatic or cannot be surgically removed.

Trial ID:

2023-506716-41-00

Protocol code:

CJDQ443E12101

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of JDQ443 and Ribociclib in Combination for Adult Patients with Advanced Solid Tumors with KRAS G12C Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?