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Study of ART6043, Olaparib, and Niraparib in Patients with Advanced or Metastatic Solid Tumors

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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 the effects of a new treatment for patients with advanced or metastatic solid tumors. These are types of cancer that have spread from their original location to other parts of the body. The study will test a medication called ART6043, which is a tablet taken by mouth. ART6043 works by blocking a specific enzyme called DNA polymerase theta, which is involved in the repair of damaged DNA in cancer cells. By inhibiting this enzyme, ART6043 may help to prevent cancer cells from repairing themselves, potentially slowing down or stopping their growth.

The purpose of the study is to assess the safety and tolerability of ART6043 when used alone and in combination with other cancer medications, such as olaparib and niraparib. Olaparib and niraparib are known as PARP inhibitors, which are drugs that also interfere with the DNA repair process in cancer cells. The study will explore how well ART6043 works when combined with these PARP inhibitors, especially in patients with specific types of breast cancer that have certain genetic mutations, like the BRCA mutation.

Participants in the study will receive ART6043 either by itself or alongside olaparib or niraparib. The study will monitor the participants for any side effects and measure how the cancer responds to the treatment. The goal is to determine the best dose of ART6043 and to see if the combination treatments are more effective than the PARP inhibitors alone. The study will take place over several years, with regular check-ups and assessments to ensure the safety and effectiveness of the treatment.

The research process

The trial runs in 6 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, the patient will begin participation in a clinical trial designed to assess the safety and effectiveness of the medication ART6043 for treating advanced or metastatic solid tumors.

    The study is divided into two main parts: Part A and Part B, each with specific objectives and treatment plans.

  2. Step 2

    Part a: initial treatment phase

    In Part A, the patient will receive ART6043 orally. The goal is to evaluate the safety and tolerability of this medication when used alone and in combination with other medications.

    The patient may also receive olaparib or niraparib in combination with ART6043. These medications are taken orally in the form of film-coated tablets.

  3. Step 3

    Part b: combination treatment phase

    Part B is divided into two sub-parts: B1 and B2. In Part B1, the patient will continue to receive ART6043 in combination with a type of medication known as PARPi (poly ADP ribose polymerase inhibitors) to further assess safety and tolerability.

    In Part B2, the focus is on evaluating the effectiveness of ART6043 in combination with PARPi compared to PARPi alone, specifically in patients with certain types of breast cancer.

  4. Step 4

    Medication administration

    The patient will take ART6043 and any combination medications orally. The specific dosage and frequency will be determined by the study protocol and the patient's response to treatment.

    The patient will be monitored for any side effects or adverse reactions throughout the study.

  5. Step 5

    Monitoring and evaluation

    Regular assessments will be conducted to monitor the patient's health and the effectiveness of the treatment. This includes tracking any side effects and measuring tumor response.

    The study aims to determine the most effective and safe dosage of ART6043 when used alone or in combination with other medications.

  6. Step 6

    Completion of the study

    The study is expected to conclude by September 30, 2026. The patient will continue to receive treatment and monitoring until the study's end or until it is deemed appropriate to discontinue participation.

    Upon completion, the data collected will contribute to understanding the safety and effectiveness of ART6043 in treating advanced or metastatic solid tumors.

Who can join the trial?

18 criteria

  • Must have stopped all previous cancer treatments, except for certain types of radiotherapy, at least 21 days before starting the study medication. Hormonal treatments for cancer should be stopped at least 7 days before, unless it's for prostate cancer.
  • For Part A2/A3: Must have advanced or metastatic cancer with specific genetic changes that affect certain genes involved in DNA repair.
  • For Part A2/A3: Must be suitable for treatment with a type of drug called PARPi, even if previously treated with it.
  • For Part B: Must have breast cancer that is locally advanced or has spread, confirmed by specific tests, and does not have a protein called HER2.
  • For Part B: Must have a specific genetic mutation known to affect breast cancer.
  • For Part B: Must have been treated with chemotherapy before, either before surgery, after surgery, or for cancer that has spread. If the breast cancer is hormone receptor positive, must have had hormone therapy before or be unsuitable for it.
  • For Part B: Must have been treated with a type of chemotherapy called taxane, unless it's not safe for them.
  • For Part B: Must have had no or up to 1 month of prior treatment with a PARPi.
  • Must have recovered from any side effects of previous treatments or surgeries.
  • Must have a performance status of 0-2 on the ECOG scale, which measures daily living abilities.
  • Must have organs that are working well enough.
  • If able to have children, must agree to use birth control during the study and for a certain time after the last dose of the study drug.
  • Must have an expected life span of at least 12 weeks, as judged by the study doctor.
  • For Part A1: Must have advanced or metastatic cancer with specific genetic changes affecting DNA repair genes.
  • For Part A1 in Spain: Must not be eligible for curative treatment and have tried standard treatments without success.
  • For Part A1/A2/A3: Must have at least one tumor that can be measured by scans, especially for prostate cancer patients.
  • Must be at least 18 years old.
  • Both males and females can participate.

Who cannot join the trial?

12 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are recovering from surgery.
  • Patients with an active infection that requires treatment.
  • Patients who have had a heart attack or stroke in the recent past.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney problems.
  • Patients who have allergies to the study medication or similar drugs.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to take oral medications.
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Investigated drugs

  • ART6043

    is a new medication being studied for its potential to treat advanced or metastatic solid tumors. It works by inhibiting a specific enzyme called DNA polymerase theta, which is involved in repairing damaged DNA in cancer cells. By blocking this enzyme, ART6043 may help to prevent cancer cells from repairing themselves, potentially leading to their death. This medication is taken orally and is being tested both on its own and in combination with other treatments.

  • Olaparib

    is a medication used in the treatment of certain types of cancer. It belongs to a class of drugs known as PARP inhibitors, which work by blocking an enzyme that helps repair DNA damage in cells. By inhibiting this enzyme, olaparib can make it harder for cancer cells to repair themselves, which may lead to their destruction. In this trial, olaparib is being used in combination with ART6043 to see if the two drugs together can be more effective than either one alone.

  • Niraparib

    is another PARP inhibitor used in cancer treatment. Similar to olaparib, it works by preventing cancer cells from repairing their DNA, which can lead to cell death. Niraparib is being tested in combination with ART6043 to evaluate whether this combination can improve treatment outcomes for patients with advanced or metastatic solid tumors.

What is already known about the treatment

ART6043 – This medication is administered orally and is currently being studied in clinical trials for its safety, tolerability, and preliminary effectiveness in treating advanced or metastatic solid tumors. It is in the early stages of research, with ongoing studies to determine its optimal dosage and potential benefits when used alone or in combination with other drugs. ART6043 is primarily indicated for patients with advanced solid tumors, including metastatic cases. It works by inhibiting DNA polymerase theta, a protein involved in DNA repair, which may help prevent cancer cells from repairing themselves and continuing to grow. ART6043 is classified as a DNA polymerase theta inhibitor, a type of targeted cancer therapy.

Investigated diseases

  • Metastatic Solid Tumors

    These are cancers that have spread from their original site to other parts of the body. The progression involves cancer cells breaking away from the primary tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs. This spread can affect various organs, including the liver, lungs, brain, and bones. The symptoms and progression depend on the location and size of the metastases. As the disease advances, it can lead to complications related to the affected organs. The condition is often challenging to manage due to its widespread nature.

  • Advanced Solid Tumors

    This term refers to cancers that have grown significantly and may have spread to nearby tissues or lymph nodes. These tumors are typically in a late stage of development, making them more difficult to treat. The progression involves the tumor increasing in size and potentially invading surrounding structures. Symptoms can vary widely depending on the tumor's location and the organs involved. As the tumor grows, it can cause pain, obstruction, or other organ-specific issues. The disease's advancement often requires comprehensive management strategies.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509220-17-00Protocol codeART6043C001Estimated enrolment120 patientsSponsorArtios Pharma Limited

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