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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
MD Anderson Cancer Center	Madrid	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario De Leon	Leon	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hdybvqiw Ulrlaknlzbsdv Mcutuie Dj Vmeaurrbrl	Santander	Spain
Ihumnqcq Cudodl Dgfsuapdqxfoombkw	L'hospitalet De Llobregat	Spain
Pknn Tbrcp Hzvyunrm Uhjndxxpjofa	Sabadell	Spain
Ayxgxhaqbb Pqofmdmc Hkcklnhw Db Pbsad	Paris	France
Aogcwuorrg Prbbhxav Hrnovjht Dy Mvylumkqs	Marseille	France
Fshqozaib Plzr Lo Iuvuhmlcbijzh Bcmubsfat Dgs Hjhzwttd Uhmuqyxgoxcln Lu Pcd	Madrid	Spain
Hqzdgpms Vjcb devnnouo	Barcelona	Spain
Hnkbpohu Uqwrmarswqbkf dp A Cglual	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.03.2023
Spain	Recruiting	20.03.2023

Trial locations

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.

Investigated diseases:

Neoplasm

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.

Trial ID:

2024-511534-12-00

Protocol code:

ART0380C001

NCT ID:

NCT04657068

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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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

What is this study about?

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