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Study of Drug Combination Treatment Based on Tumor Molecular Changes in Patients with Advanced or Metastatic Cancer

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What is this trial about?

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

This study focuses on patients with advanced cancer or metastatic tumors that have specific molecular changes. The study will test several anti-cancer medications including ribociclib, siremadlin (HDM201), trametinib, dabrafenib, alectinib, regorafenib, cabozantinib, and avapritinib. These medications are designed to target specific changes found in cancer cells.

The purpose of this research is to evaluate how well these medications work when matched to specific molecular changes in a patient's tumor. Each medication will be used to treat cancers that have particular genetic alterations that the drug is designed to target. For example, some patients will receive treatment with trametinib and dabrafenib if their tumor has a specific type of BRAF mutation.

During the study, participants will receive their assigned medication and will be monitored for how their cancer responds to treatment. The medications are taken by mouth daily, and patients will be followed for up to 60 months to assess how well the treatment works. The study will measure if the cancer stops growing or shrinks, and how long any benefits from the treatment last.

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

    Initial assessment

    A molecular examination of your tumor will determine if you qualify for one of the specific treatment groups.

    Your doctor will perform tests to verify your overall health status and measure your ECOG performance score (a measure of your daily activity level).

    Laboratory tests will check your organ function within 7 days before starting treatment.

  2. Step 2

    Treatment assignment

    Based on your tumor's molecular profile, you will be assigned to one of these treatment groups:

    - Cabozantinib tablets for specific gene changes in AXL, MET, VEGFR and other genes

    - Alectinib capsules for ALK gene changes

    - Regorafenib tablets for changes in VEGFR, TIE-2, KIT and other specific genes

    - Trametinib with dabrafenib tablets for BRAF V600 gene change

    - Avapritinib tablets for specific KIT or PDGFRA gene changes

  3. Step 3

    Treatment period

    You will take your assigned medication(s) by mouth daily

    Your treatment will continue as long as it remains beneficial

    Regular assessments will track your tumor's response to treatment

    The main evaluation point will occur after 3 months (12 weeks) of treatment

  4. Step 4

    Monitoring

    Your tumor will be measured regularly using imaging scans

    Blood tests will monitor your organ function

    Side effects will be assessed using a standardized scale (CTCAE v5.0)

    Treatment will continue until your disease progresses or you experience unacceptable side effects

  5. Step 5

    Follow-up period

    After treatment ends, your health status will continue to be monitored

    Long-term response will be evaluated, particularly if you respond for more than 6 months

    Overall survival and progression-free survival data will be collected

Who can join the trial?

12 criteria

  • Must be at least 18 years old when signing the consent form

  • Must have advanced or metastatic cancer (cancer that has spread or cannot be surgically removed) that either:

    • Has not responded to standard treatments
    • Has no standard treatment options available
    • Is not suitable for standard treatments according to the doctor
  • Must have had at least one previous treatment for advanced/metastatic cancer
  • Must have cancer that can be measured on scans according to RECIST criteria (a standardized way to measure tumors)
  • Must have good physical functioning ability (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must have adequate organ function based on laboratory tests
  • Must have specific genetic changes in their tumor that match one of the study treatment groups
  • Any side effects from previous cancer treatments must be resolved or mild (except for hair loss, mild nerve problems, or anemia)
  • Must be willing and able to follow study procedures and sign informed consent
  • Must have medical insurance
  • Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
  • Both men and women must use effective birth control during the study (duration depends on treatment group)

Who cannot join the trial?

13 criteria

  • Age below 18 years old
  • Pregnancy or breastfeeding
  • Active brain metastases (cancer that has spread to the brain) that are not treated or stable
  • History of severe allergic reactions to study medications
  • Serious heart conditions, including heart failure (when heart cannot pump blood effectively), unstable angina (chest pain), or recent heart attack
  • Severe liver problems with liver function tests more than 3 times the normal limit
  • Severe kidney problems with creatinine clearance (a measure of kidney function) less than 30 mL/min
  • Active, uncontrolled infections
  • Other cancers diagnosed within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Participation in another clinical trial within 30 days before starting this study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to swallow oral medications
  • Mental conditions that would interfere with following study procedures
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Investigated drugs

Avapritinib
Avapritinib is a pill taken by mouth that blocks specific proteins called KIT and PDGFRA that can be abnormal in some cancers. By stopping these proteins, the drug aims to slow down the growth of tumors that have these changes. HDM201
HDM201, also known as siremadlin, is an oral medication that works by re‑activating a natural tumor‑blocking protein called p53. It does this by stopping another protein, MDM2, from turning p53 off, helping the body’s own defenses to fight cancer cells. Regorafenib
Regorafenib is a pill that blocks several enzymes (kinases) that help tumors grow, spread, and form new blood vessels. By inhibiting these enzymes, the drug tries to limit the tumor’s ability to expand. Ribociclib
Ribociclib is an oral drug that stops cancer cells from dividing by blocking proteins called CDK4 and CDK6. This slows the growth of tumors that rely on these proteins to multiply. Alectinib
Alectinib is a mouth‑taken medication that targets a protein called ALK, which can be abnormally active in some cancers. By blocking ALK, the drug works to reduce tumor growth in patients whose tumors have this change. Dabrafenib
Dabrafenib is an oral pill that blocks the BRAF protein when it is mutated. The drug stops the signals that tell cancer cells to grow, helping to control tumors with a BRAF mutation. Trametinib
Trametinib is taken by mouth and blocks a protein called MEK, which is part of the same growth pathway as BRAF. It is often used together with BRAF‑blocking drugs to more effectively stop tumor growth. Cabozantinib
Cabozantinib is an oral medication that blocks several proteins, including VEGFR, MET, and AXL. By inhibiting these proteins, the drug reduces tumor growth and the formation of new blood vessels that feed the tumor.

What is already known about the treatment

  • AVAPRITINIB

    This drug is taken by mouth as a tablet. It is still an experimental medicine that is being studied in clinical trials and is not yet approved for regular use. It is being tested for treating advanced cancers that have specific genetic changes. It works by blocking a protein called FLT3 that helps cancer cells grow, and it belongs to the class of targeted kinase inhibitors.

  • SIREMADLIN

    Siremadlin is given as a hard capsule taken orally. It is an investigational agent currently in early‑stage trials and not yet approved for general medical use. It is being explored for use in advanced solid tumors that have certain molecular features. It blocks a protein called MDM2, which allows the tumor‑suppressing protein p53 to work better, and it is classified as an MDM2‑p53 interaction inhibitor.

  • REGORAFENIB

    Regorafenib is an oral tablet taken by mouth. It is an approved cancer medicine used in several types of advanced cancers, such as colorectal and liver cancer. It is used when the disease has spread or cannot be treated with other drugs. It blocks multiple proteins that help tumors grow and form new blood vessels, and it is classified as a multi‑kinase inhibitor.

  • RIBOCICLIB

    Ribociclib comes as an oral tablet. It is an approved treatment for certain breast cancers that have hormone receptors. It is used when the cancer is advanced or has returned after other therapy. It works by stopping proteins called CDK4 and CDK6 that tell cells to divide, and it belongs to the class of CDK4/6 inhibitors.

  • ALECTINIB

    Alectinib is taken as an oral tablet. It is an approved drug for a type of lung cancer that has an ALK genetic alteration. It is used when the disease is advanced or has spread. It blocks the ALK protein that drives cancer growth, and it is classified as an ALK‑targeted kinase inhibitor.

  • DABRAFENIB

    Dabrafenib is an oral tablet taken by mouth. It is approved for treating melanoma and other cancers that have a BRAF V600 mutation. It is used when the cancer is advanced or cannot be removed by surgery. It blocks the mutant BRAF protein that tells cancer cells to multiply, and it belongs to the class of BRAF kinase inhibitors.

Investigated diseases

  • Advanced Cancer

    A condition where cancer cells have spread beyond their original location to other parts of the body through the bloodstream or lymphatic system. In this stage, cancer cells form new tumors in different organs or tissues, known as metastases. The disease typically develops gradually, with cancer cells first growing locally, then breaking away from the original tumor and traveling through the body. These cells can establish themselves in new locations, forming secondary tumors that may affect the function of involved organs.

  • Metastatic Cancer

    A phase of cancer where malignant cells have spread from their primary site to other locations in the body. The process begins when cancer cells break away from the original tumor and travel through blood vessels or lymph nodes to reach distant organs. These cells then establish themselves in new locations, where they multiply and form additional tumors. The disease can affect multiple body systems simultaneously, depending on where the cancer spreads.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510567-35-00Protocol codeET19-073Estimated enrolment455 patientsSponsorCentre Leon Berard

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