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Gen1046

GEN1046, also known as Acasunlimab or DuoBody-PD-L1x4-1BB, is an innovative bispecific antibody being investigated in clinical trials for the treatment of various advanced solid tumors. This article summarizes key information about ongoing studies evaluating GEN1046 alone and in combination with other cancer therapies, focusing on its potential benefits for patients with endometrial cancer, non-small cell lung cancer, and other malignancies.

Table of Contents

What is GEN1046?

GEN1046, also known as DuoBody®-PD-L1x4-1BB, is an investigational drug being studied for the treatment of advanced endometrial cancer. It is a type of medication called an immunotherapy, which means it works by helping your body’s immune system fight cancer cells.[1]

Target Condition: Advanced Endometrial Cancer

Endometrial cancer is a type of cancer that starts in the lining of the uterus (womb). When it’s described as “advanced,” it means the cancer is at a later stage and has either spread to nearby tissues or other parts of the body, making it more difficult to treat with standard methods.[1]

How GEN1046 Works

GEN1046 is a unique type of immunotherapy that targets two different parts of the immune system:

  • PD-L1 (Programmed Death-Ligand 1): This is a protein found on some cancer cells that helps them hide from the immune system.
  • 4-1BB: This is a protein on immune cells that, when activated, can boost the immune response against cancer.

By targeting both of these proteins, GEN1046 aims to make cancer cells more visible to the immune system and simultaneously boost the immune system’s ability to attack these cells.[1]

Clinical Trial Details

A clinical trial is currently underway to study GEN1046 in combination with another immunotherapy drug called pembrolizumab for patients with advanced endometrial cancer. Here are some key details about the trial:

  • It’s a Phase 2 trial, which means it’s testing how well the treatment works and looking for any side effects.
  • The trial is “open-label,” meaning both patients and doctors know which treatment is being given.
  • The main goal is to see how effective GEN1046 is when combined with pembrolizumab in treating advanced endometrial cancer.
  • The trial is also looking at how safe the combination is and how well patients tolerate it.[1]

Eligibility Criteria

To participate in this trial, patients must meet certain criteria. Some of the main requirements include:

  • Having advanced endometrial cancer that has not responded to or has come back after standard first-line treatment.
  • Having a specific type of tumor called dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high), which can be determined through special testing.
  • Having received at least one, but no more than two, prior chemotherapy treatments for advanced endometrial cancer.
  • For one group in the study (Cohort A), patients must not have received any prior immunotherapy treatments.
  • For another group (Cohort B), patients must have received and progressed on a prior PD-1/PD-L1 inhibitor treatment.[1]

Potential Benefits

The researchers are hoping to see several potential benefits from this treatment combination:

  • Improved tumor response: They will measure how many patients see their tumors shrink or disappear (called the “objective response rate”).
  • Longer-lasting effects: They’ll look at how long the treatment keeps working for patients who respond.
  • Better disease control: This includes not just shrinking tumors, but also keeping them from growing.
  • Quicker responses: They’ll measure how quickly patients start to see benefits from the treatment.[1]

Safety Considerations

As with any new treatment, safety is a top priority. The researchers will be closely monitoring patients for any side effects or adverse reactions. Some specific safety considerations include:

  • Patients with a history of certain lung problems (like pneumonitis) are not eligible for the trial.
  • The study will track both the frequency and severity of any side effects.
  • Special attention will be paid to immune-related side effects, which can occur with immunotherapy treatments.
  • Patients will have regular check-ups and lab tests to monitor their health throughout the trial.[1]

It’s important to note that while GEN1046 shows promise, it is still an experimental treatment. The purpose of this clinical trial is to gather more information about its effectiveness and safety. Patients considering participation should discuss the potential risks and benefits thoroughly with their healthcare team.

Aspect Details
Drug Name GEN1046 (Acasunlimab, DuoBody-PD-L1x4-1BB)
Drug Type Bispecific antibody targeting PD-L1 and 4-1BB
Administration Intravenous infusion
Cancer Types Studied Advanced solid tumors including endometrial cancer, NSCLC, urothelial carcinoma, TNBC, SCCHN, cervical cancer
Key Trial Objectives Evaluate safety, efficacy, determine optimal dosing, assess combination with other therapies
Primary Endpoints Objective Response Rate (ORR), safety/tolerability
Secondary Endpoints Duration of Response, Progression-Free Survival, Overall Survival
Patient Eligibility Advanced/metastatic disease, prior treatment history, adequate organ function, biomarker status (e.g., PD-L1 expression)

FAQ

  • What is GEN1046 and how does it work? GEN1046, also called Acasunlimab, is a bispecific antibody that targets both PD-L1 and 4-1BB proteins. It's designed to stimulate the immune system to fight cancer cells while also blocking signals that can suppress immune responses.
  • What types of cancer is GEN1046 being studied for? GEN1046 is being investigated for various advanced solid tumors, including endometrial cancer, non-small cell lung cancer (NSCLC), urothelial carcinoma, triple-negative breast cancer, head and neck cancer, and cervical cancer.
  • How is GEN1046 given to patients in clinical trials? GEN1046 is administered as an intravenous infusion. The exact dosing schedule may vary depending on the specific trial, but it's typically given every few weeks.
  • What are some potential side effects of GEN1046? While specific side effects are still being studied, common side effects of immunotherapy drugs like GEN1046 can include fatigue, nausea, and immune-related reactions. The trials are closely monitoring for any adverse events to establish the safety profile.
  • How can patients find out if they're eligible for a GEN1046 clinical trial? Eligibility criteria vary by trial but generally include having advanced cancer that has progressed on standard treatments, adequate organ function, and specific biomarker status (like PD-L1 expression for some studies). Patients should discuss potential trial options with their oncologist.

Ongoing Clinical Trials on Gen1046

  • Study on GEN1046 and Pembrolizumab for Patients with Advanced Endometrial Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Italy Poland Spain

Glossary

  • Bispecific antibody: A type of engineered antibody that can bind to two different targets simultaneously, in this case PD-L1 and 4-1BB.
  • PD-L1: Programmed Death-Ligand 1, a protein that helps cancer cells evade the immune system.
  • 4-1BB (CD137): A protein on immune cells that, when activated, can enhance the anti-tumor immune response.
  • Checkpoint inhibitor (CPI): A type of immunotherapy drug that blocks proteins that prevent T cells from killing cancer cells.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Dose-Limiting Toxicity (DLT): Side effects that are severe enough to prevent an increase in the dose of a drug during a clinical trial.

References

  1. http://clinicaltrials.eu/trial/study-on-gen1046-and-pembrolizumab-for-patients-with-advanced-endometrial-cancer/