Testing a new drug for advanced cancer or lymphomas

Recruting new patients

Select region:

Navigation:

    What is this study about?

    In this research, the researchers are testing a new drug called OSE-279 that might help fight cancer. The researchers are looking for people who have very advanced forms of cancer, like tumors or lymphoma, which are not responding to other treatments. This study has two main parts. First, it is important to try to find the right dose of the drug that is safe but also effective. Then, the researchers expand the trial with more people to see how well it works. Main measurements are how much the cancer shrinks (responses), how long it stays like that (response duration), to evaluate the drug’s effectiveness.

    Learn more about this Trial

      I accept the Terms of Use and Privacy Policy*

       I consent to the Service Operator sending commercial information*

      I consent to the Service Operator using telecommunications terminal devices and automatic calling systems in marketing communications*

      Success

      Your form submitted successfully!

      Error

      Sorry! your form was not submitted properly, Please check the errors above.

      Locations

      Where does the clinical trial take place?

      Anderlecht , Belgium

      Lyon , France

      Rennes , France

      Saint-Herblain , France

      Toulouse , France

      Villejuif , France

      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 need to take the drug OSE-279 at one of the following dose levels:

      1. 100 mg – Dose Level 1
      2. 300 mg – Dose Level 2
      3. 500 mg – Dose Level 3

      Each dose level corresponds to an experimental arm of the study, and OSE-279 is described as a human IgG4 monoclonal antibody against PD-1. Unfortunately, the document does not specify the frequency or period over which the drug should be taken. For more detailed information regarding the schedule and administration, I will need to continue searching or browse through a broader section of the document. Would you like me to find more details on the administration schedule for the drug?


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

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

      1. Advanced solid tumors or lymphomas for which an anti-PD-1/PD-L1 therapy has shown efficacy, such as those with high microsatellite instability (MSI-H), but is not available in the center or country.
      2. Rare tumors with reported significant activity of anti-PD-1, for example, Tertiary Lymphoid Structures positive (TLS+) sarcomas, alveolar soft part sarcomas, etc.
      3. PD-L1 positive tumors.

      These are the disease criteria that make you eligible to participate in the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      The conditions you must meet to join the study, along with explanations of the medical terms, are as follows:

      Inclusion Criteria:

      1. Age and Gender: You must be an adult patient, either male or female.
      2. Informed Consent: You must have signed and dated the informed consent form prior to any trial-specific procedures. Furthermore, you should be able and willing to comply with study visits and procedures as per the study protocol.
      3. Performance Status: You must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The ECOG scale is used to assess how a patient’s disease is progressing, how the disease affects the day-to-day abilities of the patient, and to determine appropriate treatment and prognosis. A status of 0 means fully active without restriction, whereas a status of 1 indicates some restriction in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
      4. Tumor Type: You must have one of the following types of tumors:
        1. Advanced solid tumors or lymphomas where an anti PD-1/PD-L1 has shown efficacy, such as tumors with high microsatellite instability (MSI-H), but this treatment is not available in the center/country.
        2. Rare tumors with reported significant activity of anti-PD-1, for example, Tertiary Lymphoid Structures positive (TLS+) sarcomas or alveolar soft part sarcomas.
        3. PD-L1 positive tumors. PD-L1 is a protein that, when present on the surface of cancer cells, can help them avoid the immune system.
      5. Prior Treatment: You must have received at least one line of systemic therapy and there should be no standard of care available for your condition.
      6. Disease Evaluation: You must have evaluable or measurable disease according to RECIST 1.1/RECIL. RECIST stands for Response Evaluation Criteria in Solid Tumors and is a set of published rules that define when cancer patients improve (“respond”), stay the same (“stable”), or worsen (“progress”) during treatments.
      7. Adequate Organ Function: Your organ functions should be adequate, as detailed below:
        1. Bone marrow function: Neutrophils ≥ 1.5 x 10^9/L, Hemoglobin ≥ 90 g/L, Platelets ≥ 100 x 10^9/L.
        2. Renal (kidney) function: Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or CKD-EPI creatinine clearance ≥ 30 mL/min. CKD-EPI is an equation to estimate kidney function.
        3. Liver function: AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 3 times ULN and bilirubin ≤ 1.5 times ULN. In the case of liver metastasis, AST and ALT ≤ 5 times ULN. For patients with Gilbert’s syndrome, total bilirubin ≤ 3 times ULN or direct bilirubin ≤ 1.5 times ULN.
      8. Social Security System: You must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.

      Please remember that participation in clinical trials is voluntary, and you should always discuss potential risks and benefits with your healthcare provider.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would prevent you from taking part in the study, with explanations for any medical terms:

      1. Eligibility for better treatment options: You are not eligible if you can be treated with surgical resection or another approved therapy that is known to provide clinical benefit.
      2. Prior anti-PD-1/PD-L1 treatment: If you have previously been treated with an approved or investigational drug that targets PD-1/PD-L1, you cannot participate.
      3. Active autoimmune disease: An autoimmune disease is a condition in which the immune system attacks the body’s own tissues. If you have an active autoimmune disease that requires systemic treatment (with drugs such as corticosteroids or other immunosuppressive medications), you are not eligible, except for certain well-managed conditions.
      4. Participation in another clinical trial: Being part of another clinical trial with a medicinal product disqualifies you from this study.
      5. Incomplete recovery from previous treatments: If you haven’t fully recovered from side effects of previous anti-cancer treatments (except for specific conditions like Grade 2 neuropathy or any Grade alopecia), you cannot join this trial.
      6. Progressing additional malignancy: If you have another cancer that is worsening or requires active treatment, you are not eligible, with certain exceptions for skin cancers and in situ cervical cancer.
      7. Active central nervous system metastases: This refers to cancer that has spread to the brain or the membranes surrounding the brain and spinal cord. If you have such metastases or carcinomatous meningitis and are not stable, you are excluded.
      8. Non-infectious pneumonitis or interstitial lung disease: These are conditions involving inflammation of the lungs. If you have a history or active case needing steroids, you cannot participate.
      9. Medical conditions or abnormalities that might interfere with the study: Any health issues or lab abnormalities that could affect study results or your ability to complete the study would disqualify you.
      10. Recent significant cardiovascular event: If you’ve had severe heart problems like a stroke, heart attack, or uncontrolled heart failure in the last six months, you are not eligible.
      11. Organ transplant recipient: If you’ve had an organ or hematopoietic stem cell transplant, you cannot take part.
      12. Forbidden treatments during the study: You cannot receive certain chemotherapy, targeted therapies, immunotherapies not mentioned in the protocol, radiation therapy, live vaccines, or have had recent major surgery. Specific periods before the screening and study drug administration are given for washout.
      13. Allergies to study drug: If you are allergic to the study drug OSE-279 or any of its components, you are not eligible.
      14. Active tuberculosis: An active infection with Mycobacterium tuberculosis disqualifies you.
      15. Active infections including hepatitis B, hepatitis C, and HIV: You cannot have active hepatitis B or C, and though HIV-positive patients may qualify under certain conditions, active HIV is exclusionary.
      16. Psychiatric or substance abuse disorders: If these conditions would interrupt your ability to follow the study protocol, you cannot participate.
      17. Contraception requirements: Women of childbearing potential (WOCBP) and men participating in the study must use highly efficient contraception to prevent pregnancy. Additionally, men should use condoms and avoid donating semen throughout the study.
      18. Pregnancy or breast feeding: Finally, if you are pregnant or breast-feeding, or if you plan to conceive during the trial timeframe, you are excluded from the study.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drug involved in the study is OSE-279, and here is a brief description of the active substance involved:

      1. Human IgG4 monoclonal antibody (mAb) against PD-1: This is an immunotherapy drug designed to block the programmed death-1 (PD-1) receptor, a protein on the surface of immune cells. By doing so, the antibody aims to reactivate the immune system to recognize and attack cancer cells. It is being tested in various dosing regimens (100 mg, 300 mg, and 500 mg) during the clinical trial.

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

      The active substance participating in the clinical trial is known as OSE-279. It is present at different dosages in the study. Here is the list of dosages along with descriptions for each:

      1. OSE-279 100mg: This is a human IgG4 monoclonal antibody (mAb) directed against programmed death-1 (PD-1). It is used at a dosage of 100 mg.
      2. OSE-279 300mg: Similar to the 100 mg version, this is also a human IgG4 monoclonal antibody against PD-1. The dosage for this arm of the clinical trial is 300 mg.
      3. OSE-279 500mg: This is the highest dosage of the human IgG4 monoclonal antibody against PD-1 in the study, with an administration of 500 mg.

      Monoclonal antibodies are widely known and used in medical science. They are engineered molecules, which can be designed to target specific antigens, such as PD-1 in the case of OSE-279. The PD-1 pathway is an immune checkpoint that, when inhibited, can potentially enhance the immune system’s anti-tumor response. Drugs targeting PD-1 have been reported in medical literature and are part of existing treatments for various cancers.


      Study ID

      CT-EU-00068687

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      I

      Medicinal Product