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

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

JDQ443 – JDQ443 is an investigational medication currently being studied in clinical trials for its potential to treat advanced solid tumors with the KRAS G12C mutation. It is administered orally, allowing for convenient dosing. The drug is in the early stages of clinical research, focusing on assessing its safety, tolerability, and effectiveness both as a single agent and in combination with other treatments like TNO155 and tislelizumab. JDQ443 works by specifically targeting the KRAS G12C mutation, which is a common driver in certain cancers, thereby inhibiting tumor growth. It is classified as a targeted cancer therapy, aiming to interfere with specific molecular pathways involved in cancer cell proliferation.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508073-87-00Protocol codeCJDQ443A12101Estimated enrolment641 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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