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Human Monoclonal Igg1 Antibody Against Netrin-1

This article discusses the ongoing clinical trials investigating the use of a novel drug called Human Monoclonal IgG1 Antibody Against Netrin-1 (NP137) in treating advanced endometrial and cervical cancers. The study aims to evaluate the safety and effectiveness of NP137 when combined with other cancer treatments, offering hope for patients who have progressed after previous chemotherapy.

Table of Contents

What is NP137?

NP137 is a new type of medicine called a humanized monoclonal antibody that targets a protein called Netrin-1[1]. It is being developed as a potential treatment for certain types of advanced gynecological cancers. This drug is also known by other names such as NP-137 or HUMAN MONOCLONAL IGG1 ANTIBODY AGAINST NETRIN-1.

To understand what this means:

  • Humanized monoclonal antibody: This is a type of protein made in a laboratory that mimics the antibodies our immune system naturally produces to fight diseases. It’s designed to target a specific substance in the body.
  • Netrin-1: This is a protein that some cancer cells produce to help them survive and spread.

Target Conditions

NP137 is being studied for the treatment of two specific types of advanced gynecological cancers[1]:

  1. Locally advanced or metastatic endometrial carcinoma: This is a cancer that starts in the lining of the uterus (womb) and has spread to nearby tissues or other parts of the body.
  2. Locally advanced or metastatic cervical carcinoma: This is a cancer that starts in the cervix (the lower part of the uterus that connects to the vagina) and has spread to nearby tissues or other parts of the body.

The drug is being tested in patients whose cancer has progressed or come back after at least one previous chemotherapy treatment[1].

How NP137 Works

NP137 works by targeting and binding to Netrin-1, a protein that some cancer cells produce in high amounts. Netrin-1 helps cancer cells survive and avoid a natural process called apoptosis, which is a form of programmed cell death. By blocking Netrin-1, NP137 may help trigger apoptosis in cancer cells, potentially slowing down or stopping the growth of the tumor[1].

Current Research

NP137 is currently being studied in a clinical trial called GYNET. This is a Phase I/II study, which means it’s in the early stages of testing in humans. The study has two main parts[1]:

  1. Phase I (safety run-in): This part aims to assess the safety of NP137 when used in combination with other cancer drugs.
  2. Phase II: This part will investigate how well NP137 works in treating the cancer when combined with other drugs.

The study is testing NP137 in combination with other cancer treatments, including:

  • Carboplatin (a chemotherapy drug)
  • Paclitaxel (another chemotherapy drug)
  • Pembrolizumab (an immunotherapy drug)

Potential Benefits

While it’s too early to know for sure how effective NP137 will be, researchers hope it might offer several potential benefits[1]:

  • Improved response to treatment: The main goal is to see if adding NP137 to existing treatments can help more patients respond to therapy.
  • Longer-lasting responses: Researchers will look at how long the responses to treatment last.
  • Improved survival: The study will track both how long patients live without their cancer getting worse (progression-free survival) and how long they live overall (overall survival).

Safety and Side Effects

As NP137 is still in early stages of testing, its full safety profile is not yet known. The current study is carefully monitoring for any side effects or safety concerns. Patients in the study will be closely watched for[1]:

  • Adverse events (side effects)
  • Changes in vital signs
  • Changes in ECG (a test of heart function)
  • Changes in blood tests

Special attention will be paid to any reactions that occur during the infusion of NP137.

Who Can Receive NP137?

Currently, NP137 is only available through clinical trials. To be eligible for the GYNET study, patients must meet specific criteria, including[1]:

  • Be women aged 18 or older
  • Have confirmed advanced endometrial or cervical cancer that has progressed after at least one previous chemotherapy treatment
  • Have adequate organ function and overall health status
  • Not have certain other medical conditions or previous treatments that might interfere with the study

It’s important to note that there are also several factors that would prevent a person from participating in the study, such as certain autoimmune diseases, active infections, or recent use of other experimental treatments.

Future Prospects

The development of NP137 represents an exciting new approach in the treatment of advanced gynecological cancers. If the current studies show promising results, it could lead to further research and potentially a new treatment option for patients who have limited choices after their cancer has progressed on initial therapies[1].

However, it’s important to remember that drug development is a long and complex process. Even if NP137 shows promise in these early studies, it will need to go through additional larger trials before it could potentially become an approved treatment.

Aspect Details
Drug Name Human Monoclonal IgG1 Antibody Against Netrin-1 (NP137)
Study Type Phase I/II, randomized, multicenter, open-label
Target Conditions Locally advanced/metastatic endometrial carcinoma or cervix carcinoma
Patient Eligibility Women ≥18 years, progressing/relapsing after at least one prior systemic chemotherapy
Treatment Combinations NP137 with carboplatin, paclitaxel, and/or pembrolizumab
Primary Objective Assess safety and clinical activity (Objective Response Rate at 3 months)
Secondary Objectives Duration of response, progression-free survival, overall survival, pharmacokinetics
Dosage Maximum daily dose: 14 mg/kg, Maximum total dose: 242 mg/kg
Administration Route Intravenous infusion
Treatment Duration Up to 12 months

FAQ

  • What is Human Monoclonal IgG1 Antibody Against Netrin-1 (NP137)? NP137 is a first-class humanized monoclonal antibody that targets Netrin-1, a protein involved in cancer growth. It's being studied as a potential treatment for advanced endometrial and cervical cancers.
  • Who is eligible for this clinical trial? The trial is for women aged 18 or older with locally advanced or metastatic endometrial or cervical cancer that has progressed or relapsed after at least one prior systemic chemotherapy. Participants must meet specific health criteria and have adequate organ function.
  • What other treatments are being combined with NP137 in this study? NP137 is being studied in combination with carboplatin (a platinum-based chemotherapy), paclitaxel (another chemotherapy drug), and/or pembrolizumab (an immunotherapy drug).
  • What are the main goals of this clinical trial? The main objectives are to assess the safety of the drug combinations and investigate their clinical activity, particularly the objective response rate after 3 months of treatment. The study also aims to evaluate other factors such as duration of response, progression-free survival, and overall survival.
  • How is the effectiveness of the treatment measured? The effectiveness is primarily measured by the objective response rate (ORR) after 3 months of treatment, which is defined as the percentage of patients whose cancer shrinks or disappears. This is evaluated using standardized criteria called RECIST v1.1 and assessed by independent reviewers.

Ongoing Clinical Trials on Human Monoclonal Igg1 Antibody Against Netrin-1

  • Study of NP137 with carboplatin, paclitaxel and pembrolizumab combination therapy for patients with advanced endometrial or cervical cancer who had prior chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. It's designed to target and interfere with specific cell processes.
  • Netrin-1: A protein involved in cell migration and cell survival, which can play a role in cancer growth and spread.
  • Endometrial Carcinoma: A type of cancer that begins in the lining of the uterus (endometrium).
  • Cervix Carcinoma: Cancer that forms in the tissues of the cervix (the organ connecting the uterus and vagina).
  • Locally Advanced Cancer: Cancer that has spread from where it started to nearby tissue or lymph nodes.
  • Metastatic Cancer: Cancer that has spread from its original site to other parts of the body.
  • Systemic Chemotherapy: Treatment with anti-cancer drugs that travel through the bloodstream, reaching and affecting cells all over the body.
  • Carboplatin: A chemotherapy drug that contains platinum and is used to treat various types of cancers.
  • Paclitaxel: A chemotherapy drug derived from the bark of the Pacific yew tree, used to treat several types of cancer.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks (partial response) or disappears completely (complete response) after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-np137-with-carboplatin-paclitaxel-and-pembrolizumab-for-advanced-endometrial-or-cervical-cancer-after-prior-chemotherapy/