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Gen1053

A groundbreaking clinical trial is underway to assess the safety and potential effectiveness of GEN1053, a new antibody treatment for patients with malignant solid tumors. This study aims to explore GEN1053 both as a standalone therapy and in combination with an immunomodulator, offering hope for patients who have limited treatment options or have not responded to standard therapies.

Table of Contents

What is GEN1053?

GEN1053, also known as HexaBody-CD27, is a new experimental drug being developed to treat various types of malignant solid tumors[1]. A malignant solid tumor is a mass of cancerous cells that forms in organs or tissues of the body. This drug is currently being studied in clinical trials to determine its safety and effectiveness in treating cancer patients.

How Does GEN1053 Work?

GEN1053 is a type of drug called an antibody. Antibodies are proteins that help your immune system fight against harmful substances in your body, including cancer cells. This particular antibody targets a protein called CD27, which is found on certain immune cells. By interacting with CD27, GEN1053 aims to boost your immune system’s ability to fight cancer[1].

What Conditions Does GEN1053 Treat?

GEN1053 is being studied for the treatment of various types of malignant solid tumors. This includes, but is not limited to[1]:

  • Head and neck squamous cell carcinoma (HNSCC): A type of cancer that begins in the cells that line the mouth, nose, and throat.
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer, accounting for about 80-85% of all cases.
  • Other advanced or metastatic solid tumors: This refers to cancers that have spread from where they started to other parts of the body.

Current Research on GEN1053

GEN1053 is currently being studied in a Phase 1/2a clinical trial. This type of trial is designed to[1]:

  1. Determine the safe dose of GEN1053 (alone and in combination with another drug called an immunomodulator)
  2. Establish the initial safety profile of the drug
  3. Understand how the drug moves through and is processed by the body (pharmacokinetics)
  4. Evaluate how the immune system responds to the drug (immunogenicity)
  5. Assess the drug’s effectiveness in fighting tumors (antitumor activity)

Who Can Participate in GEN1053 Trials?

The current clinical trial for GEN1053 has specific criteria for who can participate. Some key requirements include[1]:

  • Being 18 years of age or older
  • Having a confirmed diagnosis of a malignant solid tumor
  • Having measurable disease according to specific criteria (RECIST 1.1)
  • Being in relatively good overall health (ECOG performance status ≤1)
  • Having adequate organ function (bone marrow, liver, kidney)

Additionally, participants should have either progressed on standard treatments, have no available standard treatments, or have refused available treatments[1].

What to Expect During Treatment

If you participate in a GEN1053 clinical trial, you can expect the following[1]:

  • GEN1053 is given as an intravenous infusion, which means it’s delivered directly into your bloodstream through a vein.
  • You may receive GEN1053 alone or in combination with another drug called an immunomodulator.
  • Your treatment will be divided into cycles, and you’ll have regular check-ups and tests to monitor your progress.
  • After your last dose, you’ll have follow-up visits at 30 and 60 days to check for any delayed side effects.

Potential Side Effects

As GEN1053 is still in early stages of testing, all potential side effects are not yet known. However, some possible side effects that researchers are monitoring include[1]:

  • Immune-related adverse events (irAEs): These are side effects caused by an overactive immune system.
  • Changes in blood cell counts
  • Changes in liver or kidney function
  • Fatigue
  • Nausea
  • Infusion-related reactions

It’s important to note that not everyone will experience these side effects, and there may be others not yet identified. Your healthcare team will monitor you closely for any adverse reactions during the trial.

Aspect Details
Drug Name GEN1053 (HexaBody-CD27)
Trial Phase Phase 1/2a
Target Condition Malignant Solid Tumors
Administration Intravenous infusion
Main Objectives Determine safe dose, assess safety profile, evaluate pharmacokinetics and immunogenicity, measure anti-tumor activity
Study Design Open-label, dose-escalation with expansion cohorts
Treatment Arms Monotherapy and combination with immunomodulator
Key Eligibility Adults with measurable disease, progressed on or no standard therapy available
Primary Endpoints Dose-limiting toxicities, adverse events, safety parameters
Secondary Endpoints Pharmacokinetics, immunogenicity, anti-tumor activity (ORR, DCR, DoR)

FAQ

  • What is GEN1053? GEN1053, also known as HexaBody-CD27, is a new antibody treatment being studied for patients with malignant solid tumors. It is designed to target specific cells in the body to help fight cancer.
  • What types of cancer is GEN1053 being tested for? GEN1053 is being tested for various types of malignant solid tumors, with a focus on head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) in the expansion phase of the trial.
  • How is GEN1053 administered? GEN1053 is administered intravenously, which means it is given through a vein in the form of a concentrate for solution for infusion.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) with measurable malignant solid tumors who have progressed on standard treatments or for whom no standard therapy is available. Specific health criteria, such as adequate organ function, must also be met.
  • What are the main goals of this clinical trial? The main goals are to determine the safe dose of GEN1053, assess its safety profile, evaluate how the body processes the drug, and measure its potential anti-tumor activity, both alone and in combination with an immunomodulator.

Ongoing Clinical Trials on Gen1053

  • Study on the Safety of GEN1053 Alone and with an Immunomodulator for Patients with Malignant Solid Tumors

    Not recruiting

    2 1 1
    Investigated drugs:
    Spain

Glossary

  • Malignant Solid Tumor: A type of cancer that forms a mass of tissue and does not contain cysts or liquid areas. These tumors can occur in various parts of the body and are considered malignant because they can spread to other areas.
  • Immunomodulator: A substance that affects the functioning of the immune system. In cancer treatment, immunomodulators are used to enhance the body's ability to fight cancer cells.
  • Monotherapy: Treatment using a single drug or method.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease.
  • Duration of Response (DoR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-of-gen1053-alone-and-with-an-immunomodulator-for-patients-with-malignant-solid-tumors/