In short
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.
Key points
- Art6043 is being studied in one authorised Phase 1/2 clinical trial. The trial includes people with advanced or metastatic solid tumors, and one part focuses on HER2-negative locally advanced or metastatic breast cancer with a gBRCA mutation. Researchers are mainly checking safety, tolerability, dose-limiting toxicities, and adverse events. They are also looking for early signs that the treatment may help, including progression-free survival. The study includes Art6043 alone and Art6043 with olaparib. The total planned enrollment is 120 people.
Trial overview
The main study of Art6043 is Phase 1/2 and is listed as authorised. It is an interventional study, which means the researchers give a treatment and then measure what happens.
This trial is studying people with advanced solid tumors and metastatic solid tumors. The study also includes a breast cancer part for patients with HER2-negative locally advanced or metastatic breast cancer with a gBRCA mutation.
The planned enrollment is 120 people.
Who can participate
The trial includes adults with advanced or metastatic solid tumors in Part A. In simple words, this means cancers that are no longer early stage and may have spread.
Part B2 is for patients with HER2-negative locally advanced or metastatic breast cancer who also have a gBRCA mutation. This is a more specific group, so the study can look at whether Art6043 may have early signs of benefit in that population.
What the study measures
In Part A, the main safety measure is the incidence of dose-limiting toxicities, often called DLTs. DLTs are side effects serious enough to limit how much treatment can be given.
Part A also measures the incidence and severity of adverse events using CTCAE v5.0. Adverse events are any unwanted medical problems seen during the study, and severity means how mild or serious they are.
In Part B2, the main efficacy measure is progression-free survival (PFS) based on RECIST v1.1. 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.
Study design and treatment groups
The study tests Art6043 orally, meaning it is taken by mouth. The trial also includes olaparib, listed in the source as Lynparza, in some treatment groups.
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. 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.
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.
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. That is why the trial focuses on DLTs, adverse events, and dose selection in Part A.
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. This helps researchers decide whether Art6043 should be studied further in larger trials.