#1 Clinical Trials Search in Europe

Regn5668

A groundbreaking clinical trial is underway to investigate the potential of REGN5668, an innovative drug being tested for the treatment of ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and endometrial cancer. This study aims to evaluate the safety and effectiveness of REGN5668 when used alone or in combination with other investigational drugs, offering new hope for patients with these challenging gynecological cancers.

Table of Contents

What is REGN5668?

REGN5668 is an investigational drug currently being studied for its potential in treating certain types of cancer[1]. An investigational drug is a medication that is still being tested in clinical trials and has not yet been approved by regulatory agencies for widespread use. REGN5668 is specifically designed to target cancer cells in a unique way, which we’ll explore further in this article.

What Conditions Does REGN5668 Target?

The clinical trial is focusing on REGN5668’s potential to treat several types of cancer[1]:

  • Ovarian cancer: A type of cancer that begins in the ovaries, which are part of the female reproductive system.
  • Fallopian tube cancer: Cancer that develops in the fallopian tubes, which connect the ovaries to the uterus.
  • Primary peritoneal cancer: A rare cancer that forms in the peritoneum, the thin layer of tissue that lines the abdomen.
  • Endometrial cancer: Also known as uterine cancer, this type starts in the lining of the uterus (called the endometrium).

How Does REGN5668 Work?

REGN5668 is described as a MUC16xCD28 costimulatory bispecific antibody[1]. Let’s break down what this means:

  • MUC16: This is a protein found on the surface of certain cancer cells, especially ovarian cancer cells.
  • CD28: This is a protein found on T cells, which are important cells in our immune system that help fight cancer.
  • Costimulatory bispecific: This means the drug is designed to bind to both MUC16 and CD28 at the same time, potentially helping to activate T cells to attack cancer cells more effectively.

By connecting these two proteins, REGN5668 aims to boost the immune system’s ability to recognize and fight cancer cells.

The Clinical Trial: Testing REGN5668’s Safety and Effectiveness

The clinical trial for REGN5668 is a Phase 1/2 study, which means it’s in the early stages of testing in humans[1]. The study has two main goals:

  1. Safety assessment: To learn about the safety of REGN5668 and identify any side effects.
  2. Efficacy evaluation: To look for signs that REGN5668 can effectively treat the targeted cancers.

The study is divided into two parts:

  • Part 1 (Escalation): This phase aims to find the highest safe dose of REGN5668 that can be given to patients.
  • Part 2 (Expansion): This phase will use the doses determined in Part 1 to further study the drug’s effects.

Combination Therapy: REGN5668 with Other Drugs

The clinical trial is not only testing REGN5668 on its own but also in combination with other drugs[1]:

  • Cemiplimab (also known as REGN2810 or Libtayo): This is another type of immunotherapy drug that helps the immune system fight cancer cells.
  • REGN4018: This is another investigational drug that targets MUC16 on cancer cells and CD3 on T cells, potentially helping T cells to directly attack cancer cells.
  • Sarilumab: This drug is being tested as a way to prevent or reduce a potential side effect called Cytokine Release Syndrome (CRS), which can occur with some types of immunotherapy.

How is REGN5668 Administered?

REGN5668 is given to patients through an intravenous (IV) infusion[1]. This means the drug is delivered directly into the bloodstream through a vein. The infusions are typically given once a week, but the exact schedule may vary depending on whether REGN5668 is being given alone or in combination with other drugs.

Potential Side Effects and Safety Monitoring

As with any investigational drug, monitoring for side effects is a crucial part of the clinical trial[1]. The researchers are carefully tracking:

  • Treatment-emergent adverse events (TEAEs): Any new medical problems or worsening of existing problems that occur during treatment.
  • Serious adverse events (SAEs): Any severe or life-threatening side effects.
  • Laboratory abnormalities: Changes in blood tests or other lab results that might indicate side effects.

One specific side effect being monitored is Cytokine Release Syndrome (CRS), which is why some patients may receive sarilumab as a preventive measure.

Future Prospects and What This Means for Patients

While REGN5668 shows promise, it’s important to remember that it’s still in the early stages of testing[1]. The researchers are looking at several key factors to determine if REGN5668 could be an effective treatment:

  • Objective Response Rate (ORR): This measures how many patients see their tumors shrink or disappear with treatment.
  • Duration of Response (DOR): This looks at how long the treatment effects last.
  • Progression-Free Survival (PFS): This measures how long patients live without their cancer getting worse.
  • Changes in CA-125 levels: CA-125 is a protein that can be elevated in some types of cancer, especially ovarian cancer. Decreases in CA-125 might indicate that the treatment is working.

If REGN5668 proves to be safe and effective in this clinical trial, it could potentially offer a new treatment option for patients with ovarian, fallopian tube, primary peritoneal, or endometrial cancers in the future. However, more research is needed before this drug could become widely available.

Aspect Details
Drug Name REGN5668
Cancer Types Ovarian, Fallopian Tube, Primary Peritoneal, Endometrial
Administration Intravenous (IV) infusion, once weekly
Combination Drugs Cemiplimab (REGN2810/Libtayo), REGN4018, Sarilumab
Primary Objectives Safety profile, Side effects, Maximum safe dose, Treatment efficacy
Study Duration Up to 5 years
Key Measurements DLTs, TEAEs, SAEs, ORR, PFS, CA-125 levels, Anti-drug antibodies

FAQ

  • What is REGN5668 and what cancers is it being tested for? REGN5668 is an investigational drug being tested for the treatment of ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and endometrial cancer. It is being studied alone and in combination with other drugs to determine its safety and effectiveness in treating these gynecological cancers.
  • How is REGN5668 administered to patients in the trial? REGN5668 is administered to patients through intravenous (IV) infusion once a week. The exact dosage and schedule may vary depending on the specific part of the trial and whether it's being used alone or in combination with other drugs.
  • What are the main goals of this clinical trial? The main goals of this trial are to determine the safety profile of REGN5668, identify any side effects, establish the highest safe dose that can be given to patients, and look for signs that the drug can effectively treat the targeted gynecological cancers.
  • What other drugs are being used in combination with REGN5668? REGN5668 is being studied in combination with cemiplimab (also known as REGN2810 or Libtayo) and REGN4018. In some cases, sarilumab may also be used to help manage potential side effects.
  • How long will the clinical trial last? The clinical trial is expected to last up to 5 years. This extended period allows researchers to thoroughly evaluate the long-term safety and effectiveness of REGN5668 and its combinations in treating gynecological cancers.

Ongoing Clinical Trials on Regn5668

  • Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or Ubamatamab for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

Glossary

  • REGN5668: An investigational drug being tested for the treatment of various gynecological cancers, administered through intravenous infusion.
  • Cemiplimab: Also known as REGN2810 or Libtayo, it's a drug used in combination with REGN5668 in some parts of the clinical trial.
  • REGN4018: Another investigational drug used in combination with REGN5668 in certain parts of the clinical trial.
  • Sarilumab: A drug administered intravenously to help prevent or reduce the severity of Cytokine Release Syndrome, a potential side effect of REGN4018.
  • Intravenous (IV) infusion: A method of delivering medication directly into a vein using a needle or catheter.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent an increase in the dose of a drug being tested in a clinical trial.
  • Cytokine Release Syndrome (CRS): A condition that can occur as a side effect of certain cancer treatments, causing symptoms such as fever, nausea, and difficulty breathing.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • iRECIST: Immune-based therapy RECIST, a modified version of RECIST used to evaluate response to immunotherapy treatments.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • CA-125: A protein found in blood that can be elevated in certain types of cancers, particularly ovarian cancer. It's often used as a tumor marker to monitor treatment response.
  • Anti-drug antibodies: Proteins produced by the immune system that can recognize and bind to drugs, potentially affecting their effectiveness or causing side effects.

References