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Study on the Safety and Effectiveness of ART0380 Alone or with Gemcitabine or Irinotecan for 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 safety and effectiveness of a new treatment for patients with advanced or metastatic solid tumors. The treatment being tested is called ART0380, which is taken orally in the form of a tablet. The study will explore how ART0380 works on its own and in combination with other medications, specifically gemcitabine and irinotecan. These medications are commonly used in cancer treatment and are administered intravenously, meaning they are given through a vein.

The purpose of the study is to assess how well patients tolerate ART0380 and to determine the best dose to use in future studies. The study will also compare the effectiveness of ART0380 when used alone and when combined with gemcitabine or irinotecan. Patients with specific types of cancer, such as high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, may receive ART0380 in combination with gemcitabine to see if this combination is more effective than gemcitabine alone.

Participants in the study will receive ART0380 either as a single treatment or in combination with one of the other medications. The study will monitor the safety of the treatment by observing any side effects and measuring how the body processes the medication. The study will also look at how long patients live without their cancer getting worse. This information will help researchers 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
A signed written informed consent is required to participate in the study.
Step 2
Treatment assignment
Participants are assigned to different parts of the study based on their specific medical condition and treatment history.
The study involves the administration of ART0380 either alone or in combination with other medications such as gemcitabine or irinotecan.
Step 3
Medication administration
For those receiving ART0380 as monotherapy, the medication is taken orally in tablet form.
Participants in combination therapy may receive gemcitabine or irinotecan intravenously, along with oral ART0380.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes checking for any side effects and measuring the response to the treatment.
Participants may undergo various tests and assessments, such as blood tests and imaging studies, to evaluate the effectiveness of the treatment.
Step 5
Completion of study
Upon completion of the study, a final assessment is conducted to gather data on the overall outcomes and any long-term effects of the treatment.
Participants are provided with information on their health status and any necessary follow-up care.

Who can join the trial?

11 criteria

Must provide a signed written informed consent.
Must be reliable and willing to be available for the duration of the study and follow study procedures.
Must have advanced or metastatic solid tumors (cancer that has spread to other parts of the body).
Must have an ECOG performance status of 0-2, which means they are fully active or have some restrictions but can still care for themselves.
Must have stopped all previous cancer treatments for at least 21 days or 5 half-lives, whichever is shorter, and recovered from any side effects to a mild level.
Must have at least one tumor that can be measured by scans or other tests.
Must have acceptable blood, kidney, liver, and blood clotting functions without needing transfusions or growth factors.
Must provide a sample of tumor tissue for analysis.
If female and of childbearing potential, or male with a female partner of childbearing potential, must use highly effective contraception plus one barrier method during the study and for 7 months (females) or 5 months (males) after the last dose.
Must have an estimated life expectancy of at least 12 weeks.
Must not have had previous treatment targeting the ATR/CHK1 pathway (a specific type of cancer treatment).

Who cannot join the trial?

11 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 within the last 5 years, except for certain skin cancers or in situ cervical cancer (a very early stage of cervical cancer).
Patients who have had major surgery within the last 4 weeks.
Patients who have not recovered from side effects of previous treatments.
Patients with known allergies to the study drugs or similar drugs.
Patients with active infections that require treatment.
Patients with certain heart conditions that are not well controlled.
Patients with brain tumors or cancer that has spread to the brain, unless treated and stable.
Patients who are unable to swallow pills.
Patients who are participating in another clinical trial.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Assistance Publique Hopitaux De Paris
Verified
Paris, France
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

ART0380
is a new medication being tested in this clinical trial. It is taken by mouth and is designed to block a specific protein in cancer cells called ATR kinase. By blocking this protein, ART0380 may help stop the growth of cancer cells. This medication is being studied to see if it is safe and how well it works in people with advanced or metastatic solid tumors. It is being tested both by itself and in combination with other cancer treatments.
Gemcitabine
is a medication that is already used to treat certain types of cancer. It works by interfering with the DNA of cancer cells, which can stop them from growing and dividing. In this trial, gemcitabine is being used in combination with ART0380 to see if the two medications together can be more effective in treating certain cancers, such as high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is resistant to platinum-based treatments.
Irinotecan
is another medication used in cancer treatment. It works by blocking an enzyme that cancer cells need to divide and grow. In this study, irinotecan is being combined with ART0380 to test if this combination can improve treatment outcomes for patients with advanced or metastatic solid tumors. The trial aims to find out if this combination is safe and how well it works in treating cancer.

What is already known about the treatment

ART0380 – ART0380 is an experimental medication taken by mouth, currently being studied for its safety and effectiveness in treating advanced or metastatic solid tumors. It is in the early stages of clinical trials, where researchers are exploring its potential benefits and side effects. The main goal is to see if ART0380 can help patients with these types of cancers, either on its own or when combined with other drugs like gemcitabine or irinotecan. ART0380 works by inhibiting a specific protein called ATR kinase, which plays a role in how cancer cells repair themselves, potentially stopping their growth.

Investigated diseases

Advanced or Metastatic Solid Tumors – These are a group of cancers that originate in solid organs or tissues and have progressed to an advanced stage, often spreading to other parts of the body. The disease begins when abnormal cells grow uncontrollably in a specific organ, forming a mass or tumor. As the disease progresses, these tumors can invade nearby tissues and spread to distant organs through the bloodstream or lymphatic system, a process known as metastasis. The progression of the disease can vary depending on the type of tumor and its location, but it generally involves the growth and spread of cancerous cells. Symptoms may arise from the tumor pressing on nearby structures or from the effects of cancer spreading to other parts of the body. The disease can affect various organs, including the lungs, liver, bones, and brain, leading to a range of symptoms depending on the organs involved.