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Study of OSE-279 and OSE2101 Drug Combination for Patients with Advanced Solid Tumors, Lymphomas, or Metastatic Non-Small Cell Lung Cancer

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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 two types of cancer: advanced solid tumors and lymphomas. The study involves two medications: OSE-279 and TEDOPI. OSE-279 is a type of medication known as a PD-1 blocking monoclonal antibody, which is designed to help the immune system fight cancer. TEDOPI is a cancer vaccine that is being tested in combination with OSE-279. The purpose of the study is to find the best dose of OSE-279 and to see how safe and effective the combination of OSE-279 and TEDOPI is for patients with these cancers.

The study is divided into three parts. In Part A, patients with advanced solid tumors or lymphomas will receive OSE-279 to determine the best dose. In Part B, the safety and tolerability of the combination of OSE-279 and TEDOPI will be evaluated in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) who have a specific genetic marker called HLA-A2. In Part C, the effectiveness of the combination treatment will be compared to OSE-279 alone in patients with the same type of lung cancer. The study will involve regular visits to the clinic for treatment and monitoring over a period of time.

Throughout the study, patients will receive either the study medications or a placebo. The study aims to assess how well the treatments work in terms of reducing the size of the tumors and improving the overall response rate. The study will also monitor any side effects experienced by the participants to ensure the treatments are safe. The trial is expected to continue until 2029, with the goal of finding new and effective treatment options for these types of cancer.

The research process

The trial runs in 7 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, the patient will provide a signed and dated informed consent form. This is necessary before any trial-specific procedures can begin.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the type of cancer and ensuring the patient meets specific health criteria, such as adequate organ function and performance status.

  3. Step 3

    Part A: dose-finding phase

    In Part A, the patient will receive OSE-279, a PD-1 blocking monoclonal antibody, through a single intravenous infusion. The goal is to determine the maximum tolerated dose and the recommended dose for the next phase. Infusions occur every 3 or 6 weeks, depending on the study's requirements.

  4. Step 4

    Part B: safety and tolerability

    In Part B, the patient will receive a combination of OSE-279 and OSE2101. The focus is on evaluating the safety and tolerability of this combination. The observation period for any dose-limiting toxicity is the first 6 weeks after the initial injections.

  5. Step 5

    Part C: antitumor activity

    In Part C, the patient will be assessed for the antitumor activity of OSE-279 in combination with OSE2101 compared to OSE-279 alone. The primary measure is the overall response rate, which includes complete and partial responses.

  6. Step 6

    Ongoing assessments

    Throughout the trial, the patient will undergo regular assessments to monitor the response to treatment and any side effects. These assessments include measuring tumor size and evaluating overall health.

  7. Step 7

    Completion of trial

    The trial is expected to continue until May 31, 2029. Upon completion, the patient will undergo a final assessment to evaluate the overall outcomes of the treatment.

Who can join the trial?

12 criteria

  • Must be a male or female adult, 18 years or older.
  • For Part B and C: Must have a specific type of lung cancer called **Stage IV Non-Small Cell Lung Cancer (NSCLC)**, which cannot be treated with surgery or radiation. The cancer should not have certain genetic changes that can be treated with specific drugs.
  • For Part B and C: Must not have received any previous treatment for cancer that affects the whole body, including treatments that help the immune system fight cancer, in the first stage of the disease.
  • For Part B and C: Must have at least one tumor that can be measured using specific medical criteria.
  • Must sign a consent form agreeing to participate in the study and be willing to follow the study's schedule and procedures.
  • Must have a good general health status, as measured by a specific scale called **ECOG performance status**.
  • For Part A: Must have advanced solid tumors or lymphomas where certain treatments have shown to work but are not available in the area, or have rare tumors that respond well to specific treatments.
  • For Part A: Must have received at least one previous treatment for cancer and have no other standard treatment options available.
  • For Part A: Must have a disease that can be evaluated or measured using specific medical criteria.
  • Must have adequate function of important organs like bone marrow, kidneys, and liver, as determined by specific medical tests.
  • Must be part of a social security system or an equivalent system, if required by local rules.
  • For Part B and C: Must have a specific genetic marker called **HLA-A2** in their blood, determined by a laboratory test. Some patients without this marker may also be included in Part C.

Who cannot join the trial?

5 criteria

  • Patients who do not have a HLA-A2 positive phenotype. This means their body does not have a specific type of protein on the surface of their cells.
  • Patients who do not have metastatic Non Small Cell Lung Cancer. This is a type of lung cancer that has spread to other parts of the body.
  • Patients who do not have advanced solid tumors or lymphomas. Solid tumors are abnormal masses of tissue, and lymphomas are cancers that start in the lymphatic system.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • OSE-279

    is a monoclonal antibody that blocks PD-1, a protein on the surface of immune cells. By blocking PD-1, this medication helps the immune system recognize and attack cancer cells more effectively. It is being studied for its potential to treat advanced solid tumors or lymphomas.

  • OSE2101

    is a cancer vaccine designed to stimulate the immune system to target and destroy cancer cells. It is used in combination with OSE-279 to enhance the immune response against tumors. This combination is being evaluated for its safety and effectiveness in treating certain types of cancer.

What is already known about the treatment

OSE-279 – This medication is administered as an intravenous infusion, typically given every 3 or 6 weeks. It is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors and lymphomas, as well as metastatic non-small cell lung cancer (NSCLC) in patients with a specific genetic marker. OSE-279 is a monoclonal antibody that works by blocking the PD-1 protein, which can help the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

  • Non-Small Cell Lung Cancer

    This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. The progression can vary significantly depending on the subtype and stage at diagnosis.

  • Advanced Solid Tumors

    These are a group of cancers that originate in solid organs or tissues, such as the breast, prostate, or colon, and have progressed to an advanced stage. At this stage, the tumors may have grown significantly or spread to other parts of the body. Symptoms depend on the location and size of the tumor and may include pain, swelling, or organ dysfunction. The disease can affect various bodily functions and may lead to complications as it progresses. The growth and spread of these tumors can vary widely based on the type of cancer and individual patient factors.

  • Lymphomas

    This is a type of cancer that begins in the lymphatic system, which is part of the body's immune system. Lymphomas are divided into two main types: Hodgkin lymphoma and non-Hodgkin lymphoma. The disease typically presents with swollen lymph nodes, fever, night sweats, and weight loss. As it progresses, it can affect other organs and tissues, leading to a range of symptoms depending on the areas involved. The progression and symptoms can vary based on the specific type and stage of lymphoma.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-514826-22-00Protocol codeOSE-279-C101Estimated enrolment70 patientsSponsorOSE Immunotherapeutics

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