#1 Clinical Trials Search in Europe

Art6043

Clinical trials are studying Art6043 in people with advanced or metastatic solid tumors and in patients with HER2-negative locally advanced or metastatic breast cancer with a gBRCA mutation. The trials aim to check safety, tolerability, dose limits, and early signs of benefit, both alone and with olaparib.

Table of Contents

Trial overview

The main study of Art6043 is Phase 1/2 and is listed as authorised.[1] It is an interventional study, which means the researchers give a treatment and then measure what happens.[1]

This trial is studying people with advanced solid tumors and metastatic solid tumors.[1] The study also includes a breast cancer part for patients with HER2-negative locally advanced or metastatic breast cancer with a gBRCA mutation.[1]

The planned enrollment is 120 people.[1]

Who can participate

The trial includes adults with advanced or metastatic solid tumors in Part A.[1] In simple words, this means cancers that are no longer early stage and may have spread.[1]

Part B2 is for patients with HER2-negative locally advanced or metastatic breast cancer who also have a gBRCA mutation.[1] This is a more specific group, so the study can look at whether Art6043 may have early signs of benefit in that population.[1]

What the study measures

In Part A, the main safety measure is the incidence of dose-limiting toxicities, often called DLTs.[1] DLTs are side effects serious enough to limit how much treatment can be given.[1]

Part A also measures the incidence and severity of adverse events using CTCAE v5.0.[1] Adverse events are any unwanted medical problems seen during the study, and severity means how mild or serious they are.[1]

In Part B2, the main efficacy measure is progression-free survival (PFS) based on RECIST v1.1.[1] PFS is the time during which the cancer does not get worse, and RECIST v1.1 is a standard way to measure tumor changes on scans.[1]

Study design and treatment groups

The study tests Art6043 orally, meaning it is taken by mouth.[1] The trial also includes olaparib, listed in the source as Lynparza, in some treatment groups.[1]

According to the trial summary, Part A is designed to find the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of Art6043, both as a single treatment and in combination with olaparib.[1] The MTD is the highest dose people can take without too many serious side effects, and the RP2D is the dose chosen for later testing.[1]

Part B2 compares Art6043 plus olaparib with olaparib alone in the breast cancer group to look for early signs that the combination may work better.[1]

Why this trial matters for patients

This trial is mainly an early research study, so its first job is to learn about safety and dose, not to prove long-term benefit.[1] That is why the trial focuses on DLTs, adverse events, and dose selection in Part A.[1]

For patients with HER2-negative breast cancer and a gBRCA mutation, the study also asks whether the combination approach may delay cancer growth compared with olaparib alone.[1] This helps researchers decide whether Art6043 should be studied further in larger trials.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05898399 Phase 1/2 Advanced/metastatic solid tumors; HER2-negative locally advanced or metastatic breast cancer with gBRCA mutation Authorised 120

FAQ

  • What is being studied in Art6043 clinical trials? The trials are studying Art6043 in adults with advanced or metastatic solid tumors. One part also studies Art6043 with olaparib in HER2-negative breast cancer with a gBRCA mutation.
  • Who may be able to join these trials? People with advanced or metastatic solid tumors may be eligible for one part of the study. Another part is for patients with HER2-negative locally advanced or metastatic breast cancer and a gBRCA mutation.
  • What phase are the Art6043 trials? The study is in Phase 1/2. This means it is looking at early safety and dose questions first, and also early signs of whether the treatment may help.
  • What are the main goals of the trials? The main goals are to check safety, tolerability, and dose limits of Art6043. The study also looks for early signs of benefit, especially by measuring progression-free survival.
  • What results are the researchers measuring? Researchers are measuring dose-limiting toxicities and adverse events in Part A. In Part B2, they are measuring progression-free survival using RECIST v1.1, which is a standard way to track tumor changes on scans.

Ongoing Clinical Trials on Art6043

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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Advanced solid tumors: Solid cancers that have grown and are no longer limited to one small area.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Locally advanced: Cancer that has grown more than early-stage disease but has not clearly spread to distant organs.
  • HER2-negative: A breast cancer that does not show high levels of the HER2 protein.
  • gBRCA mutation: A change in a BRCA gene that is present in the body’s cells and can affect cancer risk and treatment choices.
  • Phase 1/2: An early stage of clinical research that checks safety, dose, and early signs of benefit.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much of a treatment can be given.
  • Adverse events: Any unwanted medical problems seen during a study, whether or not they are caused by the treatment.
  • Tolerability: How well patients can take a treatment without major problems.
  • Progression-free survival: The length of time during and after treatment that the cancer does not get worse.
  • RECIST v1.1: A standard set of rules used to measure tumor changes on scans.

References