Study of EOS884448, Dostarlimab, and Inupadenant for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for advanced solid tumors, which are cancers that have spread beyond their original location and are not easily treatable with standard methods. The study involves several medications, including EOS884448 (also known as EOS-448), dostarlimab, inupadenant (also referred to as EOS100850), pembrolizumab (marketed as Keytruda), and inupadenant hydrochloride. These treatments are being tested in combination with each other and with standard care to explore their safety and effectiveness in treating these types of cancers.

The purpose of the study is to find the best dose of these medications and to assess their ability to fight cancer. The study is divided into two parts. The first part focuses on finding the right dose and understanding how safe and tolerable the treatments are. The second part looks at how well the treatments work against specific types of cancer, such as metastatic non-small-cell lung cancer (mNSCLC), metastatic head and neck squamous cell carcinoma (mHNSCC), and metastatic cutaneous melanoma that is resistant to certain therapies. Participants will receive the treatments either through an infusion, which is a way to deliver medication directly into the bloodstream, or in capsule form, which is taken by mouth.

Throughout the study, participants will be monitored for any side effects and how their cancer responds to the treatment. The study aims to provide valuable information on the potential benefits and risks of these new treatment combinations for people with advanced solid tumors. The trial is expected to continue until 2025, allowing researchers to gather comprehensive data on the effectiveness and safety of these treatments.

1 joining the study

Upon joining the study, consent is required for participation and for biopsies before and during treatment. Biopsies are optional in certain parts of the study.

2 part 1 – dose finding

The initial phase involves determining the safe dosage of the study drugs. This includes the combination of EOS-448 with standard treatments and investigational therapies, as well as dostarlimab with inupadenant HCl.

Participants receive these medications to assess safety and tolerability. The goal is to find the recommended dose for the next phase.

3 part 2 – expansion

This phase evaluates the effectiveness of the drug combinations in different types of cancer.

For non-small-cell lung cancer, EOS-448 is combined with pembrolizumab. For head and neck cancer, EOS-448 is combined with dostarlimab. For melanoma, EOS-448 is combined with inupadenant HCl.

The focus is on assessing the antitumor activity and further evaluating safety and tolerability.

4 medication administration

Medications are administered either intravenously or orally, depending on the specific drug and combination.

Inupadenant is taken orally in capsule form. KEYTRUDA (pembrolizumab) and JEMPERLI (dostarlimab) are given as intravenous infusions.

5 monitoring and assessments

Throughout the trial, regular monitoring of health status is conducted. This includes checking for any side effects, changes in vital signs, and laboratory tests.

Participants may undergo additional biopsies and imaging tests to assess the response to treatment.

6 completion of the trial

The trial is expected to conclude by August 2025. Participants will have follow-up visits to monitor long-term effects and overall health.

Who Can Join the Study?

Sign a written informed consent for the trial and agree to biopsies before and during the study treatment. Some parts of the study may have optional biopsies.
Be at least 18 years old on the day of signing the informed consent.
Have a confirmed diagnosis of advanced or metastatic solid tumors, which means the cancer has spread and no standard treatment with a survival benefit is available.
Have measurable disease, which means the cancer can be measured by doctors to see if it is getting better or worse.
Have a predicted life expectancy of at least 16 weeks.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Have adequate organ function, which includes specific levels of blood and liver tests that show your organs are working well enough for the study.
Female participants who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for a certain period after.
Male participants with female partners who can have children must agree to use condoms or remain abstinent during the study and for a certain period after. They must also not donate sperm during this time.
For specific parts of the study, additional criteria may apply, such as having certain types of cancer or specific test results.

Who Cannot Join the Study?

Patients who have not been diagnosed with advanced solid tumors cannot participate. Advanced solid tumors are a type of cancer that has spread and formed solid masses in the body.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible to participate.
Patients who are not able to provide informed consent, which means they cannot fully understand the study and agree to participate, cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario De Jaen	Jaen	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
CHU Helora	La Louviere	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Clinique Victor Hugo	Le Mans	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
CHU Bordeauxt	Bordeaux	France
Ctvycybdc Unjydsumbhsmgp Sijthiihm	Woluwe-Saint-Lambert	Belgium
Ardoidq Oluyoifitki Udaksalpdpdzl Pdmyz	Parma	Italy
Cydjjv Lawg Bwwjfe	Lyon	France
Hvflyjvu Usjaumcrnnvha Dt Bkxaaql	Badajoz	Spain
Unrttegfqu Hewsgfndt Pjjts Sfzrbbpcmlt Ckpsrmt Foep	Paris	France
Hfivbgnd Vdup dorryojx	Barcelona	Spain
Cwrnpa Odrcd Lsauudy	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.06.2021
France	Not recruiting	30.06.2021
Italy	Not recruiting	30.06.2021
Spain	Not recruiting	30.06.2021

Trial locations

Investigated drugs:

EOS884448 (EOS-448) is an investigational medication being studied for its potential to treat advanced solid tumors. It is being tested in combination with other standard treatments and investigational therapies to determine its safety, tolerability, and effectiveness in fighting cancer.

Dostarlimab is a medication used in this trial to help the immune system recognize and attack cancer cells. It is being combined with other investigational drugs to see if it can improve treatment outcomes for patients with advanced solid tumors.

Inupadenant is an investigational drug that is being tested in combination with dostarlimab. The goal is to see if this combination can enhance the body’s immune response against cancer, particularly in patients whose cancer has resisted other treatments.

Pembrolizumab is a medication that helps the immune system target and destroy cancer cells. In this trial, it is being combined with EOS-448 to evaluate its effectiveness in treating certain types of advanced cancer, such as metastatic non-small-cell lung cancer.

Investigated diseases:

Neoplasm

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body through the bloodstream or lymphatic system. The progression of these tumors can lead to symptoms such as pain, swelling, or dysfunction of the affected organ. The specific symptoms and progression depend on the tumor’s location and the organs involved. Advanced solid tumors often require comprehensive management due to their complex nature.

Trial ID:

2024-512227-36-00

Protocol code:

TIG-006

NCT ID:

NCT05060432

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of EOS884448, Dostarlimab, and Inupadenant for Patients with Advanced Solid Tumors

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