Not recruiting

Study of ART0380 for Patients with Advanced or Metastatic Solid Tumors

Fast replyInvestigationalNo 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 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 treatment being tested is a medication known by its code name, ART0380, which is taken orally. The purpose of the study is to determine how effective ART0380 is in treating these types of cancers.

Participants in the study will receive ART0380 as a single treatment, without combining it with other cancer therapies. The study will observe how the tumors respond to the treatment over time. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of ART0380. The study will also monitor any side effects that participants may experience and how long they can live without the cancer getting worse.

The trial is designed to include patients who have specific types of solid tumors that have been biologically selected, meaning they have certain characteristics that make them suitable for this study. The study will continue until the estimated end date in 2025, with the goal of gathering enough information to understand the potential benefits and risks of ART0380 for treating advanced or metastatic solid tumors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatments, and health status.
Participants must be at least 18 years old and have advanced or metastatic solid tumors.
Previous cancer treatments should have been completed at least 21 days prior to starting the study treatment.
Step 2
Treatment initiation
The study involves taking an oral medication called ART0380, which is an ATR kinase inhibitor.
The medication is administered as a monotherapy, meaning it is the only treatment given during the study.
Step 3
Treatment administration
Participants will take the medication according to the prescribed dosage and schedule provided by the study team.
Regular monitoring will occur to assess the medication's effects and any side effects experienced.
Step 4
Evaluation and monitoring
The primary goal is to measure the Objective Response Rate (ORR), which evaluates how well the tumor responds to the treatment.
Secondary evaluations include monitoring the incidence and severity of any adverse effects, progression-free survival, and overall survival.
Regular assessments will be conducted to track changes in tumor size and overall health status.
Step 5
Study completion
The study is expected to continue until March 31, 2025.
Participants will be followed up until the study's end date or until they are no longer able to participate due to health reasons.

Who can join the trial?

14 criteria

Must be at least 18 years old.
For Arm 1: Must have received taxane or platinum chemotherapy unless there is a medical reason not to.
For Arm 1: Must have a disease that can be measured.
For Arm 2: Must have advanced or metastatic solid cancers of any type with specific biological characteristics.
For Arm 2: If a PD-1/PDL-1 inhibitor (like pembrolizumab) is approved and available for your cancer, you should have received this treatment before joining the study.
For Arm 2: Must have a disease that can be evaluated using imaging tests.
Must have stopped all previous cancer treatments for at least 21 days or 5 half-lives, whichever is shorter. This does not include palliative radiotherapy at specific sites, which must have been completed 1 week before starting the study treatment.
Any side effects from previous treatments or surgeries must have returned to the level they were before treatment or to a mild level, except for low thyroid function needing medication, nerve damage, and hair loss, which must have improved to a mild or moderate level.
Must have organs that are working well enough.
If you or your partner can have children, you must use highly effective birth control.
Must have an estimated life expectancy of at least 12 weeks, as judged by the study doctor.
Must have a performance status of 0-1 on the ECOG scale, which measures how well you can carry out daily activities.
Must have a sufficient sample of tumor tissue that has not been treated with radiation, either from a previous sample or a new biopsy.
For Arm 1: Must have persistent or recurrent Endometrial Cancer with specific biological characteristics.

Who cannot join the trial?

3 criteria

Patients who do not have advanced or metastatic solid tumors. This means the cancer has not spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population that the study does not include.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Centre Francois Baclesse
Verified
Caen, France
Hospital Universitario De Jaen
Responsive
Jaen, Spain

Trial locations

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Investigated drugs

ART0380 is an experimental medication being tested in this clinical trial. It is an ATR kinase inhibitor, which means it is designed to block a specific protein that helps cancer cells repair their DNA. By inhibiting this protein, ART0380 aims to prevent cancer cells from repairing themselves, potentially leading to their death. This medication is taken orally and is being studied as a treatment for patients with advanced or metastatic solid tumors. The trial is focused on understanding how effective ART0380 is in treating these types of cancers.

What is already known about the treatment

ART0380 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic solid tumors. It is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for ART0380 is its potential use in patients with specific types of solid tumors. At the molecular level, ART0380 works by inhibiting ATR kinase, a protein that plays a role in DNA repair, thereby potentially preventing cancer cells from repairing themselves and continuing to grow. It is classified pharmacologically as an ATR kinase inhibitor.

Investigated diseases

Advanced or Metastatic Solid Tumors – These are cancers that originate in solid organs or tissues and have progressed to an advanced stage, often spreading to other parts of the body. Solid tumors can arise in various organs such as the lungs, liver, pancreas, or colon. When they become metastatic, it means the cancer cells have traveled from the original site to other areas, forming new tumors. The progression of these tumors can vary widely depending on the type of cancer and its location. They often grow and spread through the bloodstream or lymphatic system. The behavior and growth rate of these tumors can significantly impact the affected organs and overall health.