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Study on the Safety and Tolerability of TransCon IL-2 β/γ, Pembrolizumab, and Chemotherapy in Adults with Advanced or Metastatic Solid Tumors

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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 the safety and tolerability of a new treatment for various types of advanced cancers. The diseases being studied include locally advanced or metastatic solid tumors, platinum-resistant ovarian cancer, post-anti-PD-1 melanoma, second-line or later cervical cancer, neoadjuvant melanoma, and neoadjuvant non-small cell lung cancer. The treatment involves a medication called TransCon IL-2 β/γ, which is being tested alone or in combination with other treatments such as pembrolizumab, a standard chemotherapy, or another medication called TransCon TLR7/8 Agonist.

The purpose of the study is to evaluate how safe and tolerable these treatments are for patients. The study will be conducted in several parts. Initially, the focus will be on determining the safest dose of TransCon IL-2 β/γ when used alone or with pembrolizumab. Later, the study will explore the safety of TransCon IL-2 β/γ when used with other treatments, including standard chemotherapy and TransCon TLR7/8 Agonist. Participants will receive these treatments through injections or infusions, depending on the specific medication being tested.

Throughout the study, researchers will monitor participants for any side effects or adverse reactions to the treatments. The study aims to find the most effective and safe way to use these new treatments for patients with advanced cancers. The trial is expected to continue until the end of 2025, with recruitment starting in November 2023.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies may be performed to assess the current state of the condition.

  2. Step 2

    Treatment plan discussion

    A detailed discussion about the treatment plan takes place. This includes information about the medications involved, their administration routes, and potential side effects.

    The treatment plan may involve the use of TransCon IL-2 β/γ alone or in combination with other medications such as pembrolizumab or TransCon TLR7/8 Agonist.

  3. Step 3

    Medication administration

    The administration of medications begins. TransCon IL-2 β/γ is given as a solution for infusion, typically through an intravenous line.

    Pembrolizumab is also administered as an intravenous infusion. The frequency and dosage depend on the specific treatment plan discussed earlier.

  4. Step 4

    Regular monitoring

    Regular monitoring is conducted to evaluate the response to treatment and to check for any side effects. This may include blood tests, imaging studies, and physical examinations.

    The frequency of these monitoring sessions is determined by the treatment plan and the specific needs of the patient.

  5. Step 5

    Dose adjustment

    Based on the monitoring results, adjustments to the medication dosage may be made to optimize treatment effectiveness and minimize side effects.

    The goal is to find the maximum tolerated dose that provides the best therapeutic benefit.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is conducted to assess the overall response to the therapy.

    This includes a final set of tests and examinations to determine the impact of the treatment on the condition.

Who can join the trial?

13 criteria

  • Must be at least 18 years old.
  • Must have adequate organ function at the start of the study. This means your organs, like your liver and kidneys, are working well enough.
  • Must have an ECOG performance status of 0, 1, or 2 for some parts of the study, and 0 or 1 for others. This is a scale that measures how well you can perform daily activities. A lower number means you are more active.
  • For certain parts of the study, you must have a type of tumor where the drug pembrolizumab is expected to work well. Pembrolizumab is a medication used to treat some cancers.
  • Must not have had more than 2 different treatments for advanced cancer that cannot be removed by surgery or has spread to other parts of the body.
  • For women with certain types of ovarian cancer, you must have cancer that has come back or gotten worse within 6 months after finishing a platinum-based treatment.
  • For people with melanoma, you must have cancer that cannot be removed by surgery or has spread, and it must have gotten worse after treatment with anti-PD-1 therapy. This is a type of cancer treatment that helps your immune system fight cancer.
  • For those with cervical cancer, you must have cancer that has spread beyond the pelvis and have had 1 or 2 previous treatments for cancer that has come back or spread.
  • For people with melanoma that can be removed by surgery, you must not have had previous radiation or systemic cancer treatment for melanoma.
  • For those with non-small cell lung cancer (NSCLC) that can be removed by surgery, you must not have had previous radiation or systemic cancer treatment for NSCLC.
  • For people with NSCLC that has spread, you must have cancer that has gotten worse after treatment with platinum-based chemotherapy and anti-PD-(L)1 therapy.
  • For those with small cell lung cancer (SCLC) that has spread, you must have cancer that has gotten worse after treatment with platinum-based chemotherapy and anti-PD-(L)1 therapy.
  • Must have at least one measurable target lesion according to RECIST 1.1 criteria. This means there is a tumor that can be measured to see if it changes in size during the study.

Who cannot join the trial?

13 criteria

  • Patients with active infections that are not controlled. This means if you have an infection that is not being treated or managed well, you cannot participate.
  • Patients who have had another cancer within the last 5 years, except for certain types of skin cancer or cervical cancer that has been treated.
  • Patients with autoimmune diseases. These are conditions where the body's immune system attacks its own tissues.
  • Patients who are currently receiving or have received certain treatments like chemotherapy or radiation therapy within a specific time frame before the study.
  • Patients with heart problems that are not stable. This includes conditions like heart failure or recent heart attacks.
  • Patients with lung diseases that are not stable, such as severe asthma or chronic obstructive pulmonary disease (COPD).
  • Patients with liver problems that are severe or not controlled.
  • Patients with kidney problems that are severe or not controlled.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within a certain time frame before this study.
  • Patients with allergies to the study drugs or similar drugs.
  • Patients with neurological disorders that are not stable. These are conditions affecting the brain and nerves.
  • Patients with psychiatric disorders that are not stable. These are mental health conditions that affect mood, thinking, and behavior.
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Investigated drugs

  • TransCon IL-2 β/γ

    is a medication being studied to see how safe and tolerable it is for people with certain types of advanced or spreading solid tumors. It is designed to help the immune system fight cancer by targeting specific pathways in the body. This medication is being tested alone and in combination with other treatments to find the best way to use it.

  • Pembrolizumab

    is a type of cancer treatment known as immunotherapy. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, pembrolizumab is used in combination with other treatments to see if it can improve outcomes for patients with advanced or spreading solid tumors.

  • Standard of Care Chemotherapy

    refers to the usual chemotherapy treatments that are commonly used to treat certain types of cancer. These treatments aim to kill or slow the growth of cancer cells. In this study, standard chemotherapy is combined with other experimental treatments to evaluate if the combination is more effective.

  • TransCon TLR7/8 Agonist

    is an experimental therapy being tested to see if it can enhance the immune system's response against cancer. It targets specific receptors in the body to potentially boost the immune system's ability to fight cancer cells. This therapy is being studied alone and in combination with other treatments to determine its effectiveness and safety.

What is already known about the treatment

TransCon IL-2 β/γ – This medication is administered as an injection and is currently being studied in clinical trials for its safety and effectiveness. It is being tested for use in treating various advanced cancers, including ovarian cancer that resists platinum-based treatments, melanoma after anti-PD-1 therapy, cervical cancer in later stages, and as a preliminary treatment for melanoma and non-small cell lung cancer. The drug works by modifying the immune system to better recognize and attack cancer cells. It belongs to a class of drugs known as immunotherapies, which help the body's immune system fight cancer.

Investigated diseases

  • Locally Advanced or Metastatic Solid Tumor Malignancies

    These are cancers that have spread beyond their original site to nearby tissues or distant parts of the body. The progression involves the growth of cancer cells that invade surrounding tissues and potentially enter the bloodstream or lymphatic system. This allows the cancer to metastasize, or spread, to other organs. The disease can affect various organs and systems, depending on the type of primary cancer. Symptoms and progression vary widely based on the location and size of the tumors. The disease can lead to significant changes in organ function and overall health.

  • Platinum-Resistant Ovarian Cancer

    This type of ovarian cancer does not respond to chemotherapy treatments that include platinum-based drugs. The disease progresses as cancer cells continue to grow and spread despite treatment. It often involves the ovaries and can extend to the abdominal cavity and other organs. The cancer cells develop mechanisms to resist the effects of chemotherapy, making treatment more challenging. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The progression can lead to further complications as the cancer spreads.

  • Post-Anti-PD-1 Melanoma

    This is a form of skin cancer that persists or progresses after treatment with anti-PD-1 therapy. The disease involves the uncontrolled growth of melanocytes, the cells responsible for skin pigment. It can spread to other parts of the body, including lymph nodes and internal organs. The progression is marked by the cancer's ability to evade the immune system, even after immunotherapy. Symptoms may include new or changing moles, skin lesions, and, if metastasized, systemic symptoms. The disease can become more aggressive over time.

  • Second Line or Later Cervical Cancer

    This refers to cervical cancer that requires additional treatment after the initial therapy has failed. The disease originates in the cervix and can spread to nearby tissues and distant organs. Progression involves the growth and spread of cancer cells that are resistant to first-line treatments. Symptoms may include abnormal vaginal bleeding, pelvic pain, and changes in urinary or bowel habits. As the disease advances, it can affect other parts of the body. The progression can lead to increased symptoms and complications.

  • Neoadjuvant Melanoma

    This is melanoma treated with therapy before the main treatment, usually surgery, to shrink the tumor. The disease involves the abnormal growth of melanocytes, which can form tumors on the skin. Progression can lead to the spread of cancer cells to lymph nodes and other organs. Neoadjuvant therapy aims to reduce the tumor size and limit the spread before surgical removal. Symptoms may include changes in skin appearance, such as new or evolving moles. The disease can become more challenging to treat if it spreads.

  • Neoadjuvant Non-Small Cell Lung Cancer

    This type of lung cancer is treated with therapy before surgery to reduce tumor size. It originates in the tissues of the lungs and is the most common type of lung cancer. The disease progresses as cancer cells grow and potentially spread to lymph nodes and other organs. Neoadjuvant therapy is used to improve surgical outcomes by shrinking the tumor. Symptoms may include persistent cough, chest pain, and shortness of breath. The progression can lead to further respiratory issues and systemic effects.

Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509143-27-00Protocol codeASND0029Estimated enrolment417 patientsSponsorAscendis Pharma Oncology Division A/S

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