Study of JDQ443, TNO155, and Tislelizumab for 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 advanced solid tumors that have a specific change in the KRAS gene, known as the KRAS G12C mutation. The study is testing a new treatment called JDQ443, which is being evaluated both on its own and in combination with other treatments. These additional treatments include TNO155 and tislelizumab. The purpose of the study is to understand the safety and how well these treatments work together.

Participants in the study will receive the treatments in different forms, such as tablets or capsules for oral use, and a solution for infusion, which is given through a vein. The study will be conducted in two main parts. The first part will focus on finding the best dose of JDQ443 alone and in combination with the other treatments. The second part will look at how effective these treatments are in shrinking the tumors and improving the condition of the patients.

Throughout the study, the safety of the treatments will be closely monitored by checking for any side effects or changes in health. The study aims to find the most suitable dose and treatment plan for future research, with the hope of providing new options for patients with advanced cancers that have the KRAS G12C mutation.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including having advanced solid tumors with the KRAS G12C mutation.

A baseline assessment is conducted to evaluate the current health status and disease characteristics.

2 dose escalation phase

The initial phase involves determining the safe dosage levels of the medication JDQ443, both as a single agent and in combination with other drugs.

Medications include JDQ443 (tablet form, oral use), TNO155 (capsule, oral use), and tislelizumab (intravenous use).

The focus is on assessing safety and identifying the maximum tolerated dose.

3 dose expansion phase

This phase evaluates the effectiveness of JDQ443 alone and in combination with TNO155 and tislelizumab.

The goal is to determine the overall response rate and safety profile in a larger group of participants.

Participants may receive JDQ443 in tablet form, TNO155 in capsule form, and tislelizumab as an infusion.

4 monitoring and follow-up

Throughout the trial, regular monitoring of health status, including laboratory tests and imaging, is conducted to track progress and any side effects.

Adjustments to medication dosages may occur based on individual responses and tolerability.

5 completion of the trial

The trial is expected to conclude by January 2027, with final assessments conducted to evaluate the long-term effects and outcomes of the treatment.

Participants may be offered follow-up care or transition to other treatment options as appropriate.

Who Can Join the Study?

Patients must have advanced solid tumors with a specific genetic change called KRAS G12C mutation.
For the Dose Escalation part, patients should have advanced tumors that cannot be removed by surgery or have spread to other parts of the body. They should have tried standard treatments or cannot tolerate them, or are not eligible for approved treatments.
For the Dose Expansion part, patients with advanced non-small cell lung cancer (NSCLC) must have received a type of chemotherapy called platinum-based chemotherapy and a treatment called immune checkpoint inhibitor therapy, unless they were not eligible for these treatments. They should not have been treated with a KRAS G12C inhibitor before.
For the Dose Expansion part, patients with advanced colorectal cancer must have received standard treatments, including specific types of chemotherapy, unless they were not eligible for these treatments. They should not have been treated with a KRAS G12C inhibitor before.
For the Dose Expansion part, patients with advanced solid tumors other than NSCLC or colorectal cancer must have tried standard treatments or cannot tolerate them, or are not eligible for approved treatments. They should not have been treated with a KRAS G12C inhibitor before.
All patients must have a performance status of 0 or 1, which means they are fully active or have some restrictions but can still do light work.
All patients must have a tumor that can be biopsied, which means a small sample of the tumor can be taken for testing.
Both male and female patients are eligible to participate.
Patients from vulnerable populations can participate.

Who Cannot Join the Study?

Patients who do not have advanced solid tumors with the KRAS G12C mutation cannot participate. This is a specific change in a gene that can affect cancer growth.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to safely tolerate the study medications cannot participate. This means if the medications might cause harm or severe side effects, the patient cannot join.
Patients who are not able to follow the study procedures or attend all required visits cannot participate. This means if a patient cannot commit to the study schedule, they cannot join.
Patients who are part of a vulnerable population that the study cannot safely include cannot participate. This refers to groups of people who might be at higher risk of harm from the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Rigshospitalet	Copenhagen	Denmark
Netherlands Cancer Institute	Amsterdam	The Netherlands
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Cyayjh Ltjj Bphpul	Lyon	France
Uinbxdinjaifnntnxjnms Ecnlc Axa	Essen	Germany
Icrssoze Cuodoz Dzmixettlmceuithu	L'hospitalet De Llobregat	Spain
Uslliluynb Hsdjwfzv Crbowoe	Cologne	Germany
Hgrlgtkk Vzcy dfdcyfmr	Barcelona	Spain
Ihtflayt Plbegmpdlfzdvjz Cigitt Csurrr	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.02.2021
Denmark	Not recruiting	15.02.2021
France	Not recruiting	15.02.2021
Germany	Not recruiting	15.02.2021
Italy	Not recruiting	15.02.2021
Spain	Not recruiting	15.02.2021
The Netherlands	Not recruiting	15.02.2021

Trial locations

Investigated drugs:

JDQ443 is a medication being studied for its potential to treat advanced solid tumors that have a specific mutation known as KRAS G12C. This medication is being tested both on its own and in combination with other treatments to determine its safety, how well it is tolerated by patients, and its effectiveness in shrinking tumors.

TNO155 is another medication involved in this study. It is being combined with JDQ443 to see if the combination can improve treatment outcomes for patients with advanced solid tumors. The study aims to find out if using these two medications together is safe and if it can help reduce the size of tumors more effectively than JDQ443 alone.

Tislelizumab is an additional medication used in this trial. It is being tested in combination with JDQ443, and also with JDQ443 and TNO155 together. The goal is to assess whether adding tislelizumab to the treatment regimen can enhance the anti-tumor effects and improve patient outcomes. The study is also looking at the safety and tolerability of these combinations.

Investigated diseases:

Advanced Solid Tumors Harboring the KRAS G12C Mutation – This condition involves a group of cancers that have spread beyond their original site and possess a specific genetic mutation known as KRAS G12C. These tumors can occur in various organs and are characterized by uncontrolled cell growth due to the mutation. The KRAS G12C mutation affects a protein involved in cell signaling pathways, leading to continuous cell division and tumor progression. As the disease advances, it may lead to symptoms depending on the location and size of the tumors. The progression of these tumors can vary, with some growing slowly while others may spread more rapidly. Understanding the mutation’s role is crucial for developing targeted therapies to manage the disease.

Trial ID:

2023-508073-87-00

Protocol code:

CJDQ443A12101

NCT ID:

NCT04699188

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of JDQ443, TNO155, and Tislelizumab for Patients with Advanced Solid Tumors with KRAS G12C Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?