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

Verified siteRegistered drugNo 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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

10 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

  • EOS884448 (EOS-448)

    This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced solid tumors. It is in the investigational stage, with ongoing research to determine its safety, tolerability, and effectiveness when combined with other therapies. EOS-448 is primarily being explored for its ability to enhance the immune system's response against cancer cells. It belongs to the class of immune checkpoint inhibitors, which work by blocking proteins that prevent the immune system from attacking cancer cells.

  • Dostarlimab

    Dostarlimab is administered intravenously and is currently being evaluated in clinical trials for its use in combination with other investigational drugs for advanced solid tumors. It is an approved medication for certain cancers but is being further studied to expand its therapeutic indications. Dostarlimab works by inhibiting the PD-1 protein on immune cells, allowing the immune system to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Inupadenant HCl

    This medication is taken orally and is under investigation in clinical trials for its potential to treat advanced solid tumors, particularly in combination with other therapies. It is not yet approved for general medical use and is being studied for its safety and effectiveness. Inupadenant HCl targets the adenosine A2A receptor, which plays a role in suppressing the immune response in the tumor environment, thereby enhancing the body's ability to fight cancer. It is classified as an adenosine receptor antagonist.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512227-36-00Protocol codeTIG-006Estimated enrolment307 patientsSponsoriTeos Belgium

sourced from the EU Clinical Trials Register and site verification

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