New drug combined with various therapies for solid tumors

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    What is this study about?

    This study evaluates EOS-448, an experimental drug, combined with standard cancer treatments or other investigational therapies in patients with advanced solid tumors. It’s an open-label trial aiming to determine the safety, tolerability, and effectiveness of various drug combinations, including EOS-448. The trial is significant for patients with challenging cancer types, seeking new treatment avenues. Participants will receive EOS-448 with other drugs like pembrolizumab, inupadenant, and dostarlimab, assessing the impact on their cancer.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Antwerpen , Belgium

      Brussels , Belgium

      Hasselt , Belgium

      Bordeaux , France

      Caen , France

      Dijon , France

      Le Mans , France

      Lyon , France

      Nantes , France

      Nice , France

      Paris , France

      Poitiers , France

      Strasbourg , France

      Meldola , Italy

      Milano , Italy

      Pavia , Italy

      Badajoz , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Castellu00f3 , Spain

      Jau00e9n , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Majadahonda , Spain

      Pamplona , Spain

      Pamplona , Spain

      Sevilla , Spain

      Valencia , Spain

      London , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients will need to follow specific steps based on the arm of the study they are enrolled in. Here are the various treatment arms and the corresponding steps:

      1. Part 1A – EOS-448 + pembrolizumab: Participants will receive EOS-448 and pembrolizumab at every cycle.
      2. Part 1B – EOS-448 + inupadenant: Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis.
      3. Part 1C – EOS-448 + inupadenant: Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis (same as Part 1B).
      4. Part 1D – EOS-448 + dostarlimab: Participants will receive EOS-448 and dostarlimab at every cycle.
      5. Part 1E – inupadenant + dostarlimab: Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis.
      6. Part 1F – EOS-448 + dostarlimab + inupadenant: Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis.
      7. Part 1G – EOS-448 + dostarlimab + chemotherapies: Participants with metastatic non-small cell lung cancer (1L mNSCLC) will receive EOS-448 and dostarlimab and standard of care chemotherapies at every cycle.
      8. Part 2C – EOS-448 + dostarlimab: Participants with 1L metastatic Head and Neck Squamous Cell Carcinoma (mHNSCC) CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle.
      9. Part 2D – EOS-448 + dostarlimab: Participants with 1L mHNSCC CPS 1 < 20 will receive EOS-448 and dostarlimab at every cycle.

      The exact dosing schedule and the duration of each treatment cycle will be provided by the study team and will be specific to each participant’s situation.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study, you need to have one of the following diseases:

      1. Part 1A/1B/1C/1D/1E/1F: Histologically or cytologically confirmed advanced or metastatic solid tumor for which no standard treatment with survival benefit is available.
      2. Part 1G (NSCLC): Histologically or cytologically confirmed previously untreated stage IV or stage III not amenable to curative chemoradiotherapy or surgery nonsquamous NSCLC or squamous NSCLC and are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Provide a signed written informed consent for the trial: You must agree to participate in the trial and sign a form that states you understand the risks and benefits of the study.
      2. Have measurable disease, per RECIST v1.1: Your disease must be able to be measured using specific criteria known as Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, which is a set of published rules that defines when cancer patients improve (“respond”), stay the same (“stable”), or worsen (“progression”) during treatments.
      3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1: This is a scale used to assess how your disease is progressing and how it affects your daily living abilities:
        1. Grade 0: Fully active, able to carry on all pre-disease performance without restriction.
        2. Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
      4. Have adequate organ functions: This means that your vital organs, such as your heart, liver, and kidneys, are working well enough to handle the procedures and treatments that are part of the trial.
      5. Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available: For these parts of the trial, you need to have a solid tumor that has spread (metastasized) and for which there are no standard treatment options that could extend your life.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions under which you cannot take part in the study, along with explanations of medical terms where applicable:

      Exclusion Criteria:

      1. Recent anti-cancer therapy: If you have received any anti-cancer therapy within 4 weeks prior to the first dose of the study treatment.
      2. Recent live vaccines: If you have received a live vaccine within 30 days prior to the first dose of the study treatment.
      3. Known primary CNS cancer: If you have a known primary Central Nervous System (CNS) cancer, which is cancer that started in the brain or spinal cord.
      4. Untreated CNS metastases: If you have known CNS metastases, which are cancer cells that have spread to the brain or spinal cord from elsewhere in the body, unless they have been previously treated and well controlled for at least 1 month.
      5. Concomitant second malignancies: If you have other simultaneous cancers, unless you achieved a complete remission at least 2 years before entering the study.
      6. History of sever pneumonitis or autoimmune disease: If you have a history of Grade ≥2 pneumonitis (inflammation of lung tissue), active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade ≥2. (Grade 2 represents moderate symptoms).
      7. Prior therapy toxicity: If you have ongoing toxicity (except for alopecia which means hair loss) related to previous anti-cancer treatment and/or surgery unless the toxicity has either resolved, returned to baseline or is Grade 1, or if it’s deemed irreversible.
      8. Cardiovascular disease: If you have uncontrolled or significant cardiovascular disease, which includes heart conditions such as uncontrolled high blood pressure, heart attack, arrhythmias, etc.
      9. Recent major surgery: If you are part of Part 1 of the study and have had major surgery within 3 weeks before initiating treatment.
      10. Recent radiotherapy: If you are part of Part 1 of the study and have received prior radiotherapy within 2 weeks of the start of the study treatment.
      11. Prior immunotherapy for H&N cancer: If you are part of Part 2 of the study (Head & Neck cancer) and have received prior immunotherapy with agents like anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

      Please consult your healthcare provider for further explanation of these medical terms if needed.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study along with a brief description of each active substance are:

      1. EOS-448 – An anti-TIGIT monoclonal antibody that is designed to engage the immune system to recognize and target cancer cells.
      2. Pembrolizumab – An anti-PD-1 monoclonal antibody that helps to prevent cancer cells from evading the immune system.
      3. Inupadenant (EOS100850) – An A2A receptor antagonist that potentially enhances the effects of immune checkpoint inhibitors and other anti-cancer therapies.
      4. Dostarlimab – Another anti-PD-1 monoclonal antibody similar to pembrolizumab, it also works to help the immune system target and destroy cancer cells.
      5. SOC Chemotherapies – Standard of care chemotherapies used in the 1L (first-line) metastatic NSCLC (non-small cell lung cancer), which are likely a combination of chemotherapy drugs standardly used to treat this type of cancer. The specific drugs are not listed here.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial you are inquiring about is evaluating different combinations of the following substances:

      1. EOS-448 – This is known as GSK4428859A or belrestotug, an anti-TIGIT monoclonal antibody. While it is under investigation in this and possibly other clinical trials, it may be considered known to the medical community, especially in association with this trial. However, it may not be widely recognized as a standard therapy, given its investigational status.
      2. Pembrolizumab – An anti-PD-1 antibody commonly known as Keytruda. This is a well-known and widely used medication in the treatment of various cancers, including advanced melanoma, non-small cell lung cancer, head and neck squamous cell cancer, and others, and is extensively covered in medical literature.
      3. Inupadenant – An investigational adenosine A2A receptor antagonist. As an investigational substance, it may not be as widely known or documented as standard therapies in medical literature but is known to the medical and scientific communities involved in its development and research.
      4. Dostarlimab – Another anti-PD-1 antibody. It is also an approved treatment known in the medical literature, particularly for the treatment of endometrial cancer.
      5. Standard of care chemotherapies – The term standard of care chemotherapies can encompass a variety of chemotherapy agents that are widely known, used, and documented in the medical literature for the treatment of non-small cell lung cancer (NSCLC).

      These substances are combined in various ways as part of the clinical trial to evaluate their safety, tolerability, and effectiveness in treating advanced cancers.


      Study ID

      CT-EU-00037985

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago