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Study of drug combination in patients with advanced cancer based on genomic profiling - ProTarget Danish nationwide trial

Verified siteRegistered drugNo 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 studies various targeted anti-cancer treatments in patients with advanced cancer. The study uses genetic testing of tumors to match patients with specific medications that may work best for their type of cancer. The medications being tested include vemurafenib, axitinib, trastuzumab emtansine, selpercatinib, olaparib, pertuzumab, alectinib, atezolizumab, avelumab, vismodegib, pemigatinib, trastuzumab, and niraparib.

The medications are given either as tablets taken by mouth or as infusions given through a vein. The purpose is to evaluate how well these targeted treatments work against cancers that have specific genetic changes. The study will look at whether tumors shrink or stop growing after 16 weeks of treatment.

During the study, patients will receive one of the targeted treatments based on their tumor's genetic profile. Doctors will monitor how the cancer responds to treatment and watch for any side effects. Patients will have regular check-ups including physical exams and imaging scans to measure their tumors. Blood samples and additional tumor samples may be collected to study how the cancer responds to treatment.

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

    Your doctor will confirm that you have advanced cancer that is no longer responding to standard treatments.

    Your medical records must show results from a genomic test or protein expression test of your tumor tissue.

    A new tumor tissue sample may need to be collected for additional testing.

  2. Step 2

    Health screening

    Your doctor will check your overall health status and organ function through blood tests.

    Your cancer will be measured using imaging scans to track changes during treatment.

    You must have at least one tumor that can be measured accurately.

  3. Step 3

    Treatment assignment

    Based on your tumor's genetic profile, you will receive one of the approved targeted cancer medications.

    The medication may be given as tablets/capsules by mouth or as an infusion into your vein.

    The specific dosing schedule will depend on which medication matches your tumor's characteristics.

  4. Step 4

    Monitoring period

    Your response to treatment will be evaluated after 16 weeks.

    Regular checks will monitor for any side effects.

    Imaging scans will measure if tumors are shrinking, staying stable, or growing.

    Blood tests will continue to check your organ function.

  5. Step 5

    Long-term follow-up

    The treatment may continue as long as it is helping and side effects are manageable.

    Additional tumor samples or blood tests may be collected to understand how the treatment is working.

    Your overall survival and time without cancer progression will be tracked.

Who can join the trial?

12 criteria

  • Must be at least 18 years old with confirmed advanced or spreading cancer that is no longer responding to standard treatments
  • Must have an ECOG performance status between 0-2 (a measure of daily living abilities and activity level)
  • Must have adequate organ function, including:
    • Acceptable blood cell counts
    • Normal liver function tests
    • Adequate kidney function
    • Must have cancer that can be measured by scans or physical examination (at least one tumor that is 20mm or larger with standard imaging, or 10mm or larger with CT/MRI)
    • Must have results from genetic testing or protein testing of their tumor from an accredited laboratory
    • Must be able to understand and sign an informed consent document
    • Must have a tumor with genetic features that suggest potential benefit from the targeted therapies used in this study
    • Must be able to swallow and tolerate oral medications if receiving oral treatment
    • Must agree to use effective birth control methods during the study and for 4-24 months after completing treatment:
      • Women who can become pregnant must use approved contraception methods
      • Men must use barrier contraception or abstain from sexual activity

Who cannot join the trial?

16 criteria

  • Age under 18 years
  • Presence of brain metastases (cancer that has spread to the brain) that are not stable or controlled
  • Severe heart conditions including:
    • Heart failure with symptoms
    • Unstable heart rhythm disorders
    • Recent heart attack (within last 6 months)
    • Active, uncontrolled infections
    • Known HIV infection (Human Immunodeficiency Virus)
    • Active hepatitis B or C (liver infections)
    • Severe kidney dysfunction requiring dialysis
    • Pregnant or breastfeeding women
    • Unable to take oral medications
    • Participation in another clinical trial within the last 30 days
    • Previous treatment with the study medication
    • Known allergic reactions to similar medications
    • Mental conditions that prevent understanding of the study requirements
    • Life expectancy less than 3 months
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Investigated drugs

  • Lynparza

    is a pill that blocks a protein called PARP, which helps cancer cells repair their DNA. In this trial, it is given to patients whose tumors have a genetic change that makes them more likely to respond to this type of drug, to see if it can shrink the tumors and how safe it is.

  • Herceptin

    is an IV medicine that targets a protein called HER2, which is found in high amounts on some breast cancers. The trial uses it to treat patients whose tumors have the HER2 protein, aiming to stop the cancer from growing and to evaluate any side effects.

  • Zejula

    is a PARP inhibitor taken as a tablet, similar to Lynparza, but it works with a slightly different chemical. It is tested in patients whose cancers have specific DNA repair gene alterations, to see if it can reduce tumor size and to monitor safety.

  • Perjeta

    is an IV infusion that also targets the HER2 protein but works at a different spot than Herceptin. In the study, it is given to patients with HER2‑positive tumors, either alone or with other drugs, to assess its ability to control the cancer and its tolerability.

  • Pemazyre

    is an oral tablet that blocks a protein called FGFR2, which can drive tumor growth in certain cancers. The trial includes it for patients whose tumors show changes in the FGFR2 gene, to test whether it can halt tumor growth and to observe any adverse effects.

  • Cotellic

    is a pill that inhibits a protein called MEK, part of a pathway that many cancers use to grow. Participants whose tumors have mutations that activate this pathway receive Cotellic in the trial to determine its effectiveness in shrinking tumors and its safety profile.

What is already known about the treatment

  • Lynparza

    This medication is taken as a film‑coated tablet taken by mouth. It is an approved PARP inhibitor used for cancers such as ovarian, breast, pancreatic and prostate that have certain genetic changes. It works by blocking the PARP enzyme that helps repair DNA, so cancer cells cannot fix their damage and die. It is classified as a targeted oral anticancer drug and is widely described in medical literature.

  • Herceptin

    This drug is given as a solution that is infused into a vein. It is an approved monoclonal antibody for HER2‑positive breast and stomach cancers. It attaches to the HER2 protein on cancer cells and stops the signals that make the cells grow. It belongs to the class of HER2‑directed antibodies and is well established in clinical practice.

  • Zejula

    Zejula comes as a film‑coated tablet taken orally. It is an approved PARP inhibitor for ovarian cancer with specific DNA repair defects. The medicine blocks the PARP enzyme, preventing cancer cells from repairing their DNA and leading to their death. It is classified as a targeted oral anticancer agent and is routinely used in treatment guidelines.

  • Perjeta

    Perjeta is supplied as a concentrate that is diluted and infused intravenously. It is an approved monoclonal antibody for HER2‑positive breast cancer, often used together with Herceptin. It binds to a different part of the HER2 protein, stopping the pairing of HER2 with other receptors and blocking growth signals. It is a HER2‑directed antibody and is a standard part of modern cancer therapy.

  • Pemazyre

    Pemazyre is taken as a tablet swallowed by mouth. It is an approved FGFR inhibitor for a type of bile duct cancer that has FGFR2 gene changes. The drug blocks the FGFR signaling pathway, which slows down tumor growth. It is classified as a targeted oral tyrosine‑kinase inhibitor and is listed in current treatment recommendations.

  • Cotellic

    Cotellic is an oral film‑coated tablet. It is an approved MEK inhibitor used for melanoma that carries a BRAF mutation, usually together with a BRAF inhibitor. It stops the MEK enzyme in the cell’s growth pathway, reducing how quickly cancer cells divide. It belongs to the class of MEK‑targeting oral anticancer drugs and is well documented in clinical studies.

Investigated diseases

Cancer - A disease characterized by abnormal cell growth where cells divide and spread uncontrollably, forming masses called tumors. Cancer can develop in almost any body tissue when genetic changes disrupt normal cell growth and division. These abnormal cells can invade nearby tissues and spread to other parts of the body through blood and lymph systems. The disease progresses when cancer cells continue to grow and potentially spread to other locations in the body through a process called metastasis. Cancer cells differ from normal cells in ways that allow them to grow out of control and become invasive. Since the trial data mentions advanced cancer with genomic variants, I should note that this refers to cancers that have specific genetic mutations affecting their growth and behavior. However, I'll maintain the simple disease description as requested, without going into treatment aspects or specific cancer types, as per the guidelines.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510527-29-00Estimated enrolment600 patientsSponsorRigshospitalet

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