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5,6-Dibromo-4-Nitro-2-Piperidin-4-Yl-1-Propan-2-Ylbenzimidazole

This article discusses the ongoing clinical trials of MEN1703, a new drug being tested for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. MEN1703, also known as 5,6-Dibromo-4-Nitro-2-Piperidin-4-Yl-1-Propan-2-Ylbenzimidazole, is being studied both as a standalone treatment and in combination with another drug called glofitamab. These trials aim to evaluate the safety, effectiveness, and potential benefits of MEN1703 for patients who have not responded well to previous treatments.

Table of Contents

What is MEN1703?

MEN1703 is an investigational drug being studied for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Its chemical name is 5,6-dibromo-4-nitro-2-piperidin-4-yl-1-propan-2-ylbenzimidazole[1]. This medication is being developed by Menarini Ricerche S.P.A. and is currently in Phase II clinical trials[1].

Target Condition: Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

B-cell non-Hodgkin lymphoma is a type of cancer that affects the lymphatic system, particularly the B-cells, which are a type of white blood cell. When the disease is described as “relapsed,” it means the cancer has returned after initial treatment. “Refractory” indicates that the cancer has not responded to standard treatments[1]. The “aggressive” nature of this lymphoma means it tends to grow and spread quickly, making it a challenging condition to treat.

How MEN1703 Works

While the exact mechanism of action is not fully detailed in the provided information, MEN1703 is being studied as a PIM inhibitor. PIM kinases are enzymes that play a role in cell survival and proliferation, and their inhibition may help slow down or stop the growth of cancer cells[1].

Clinical Trial Details

The clinical trial for MEN1703 (known as JASPIS-01) is an open-label, Phase 2 study. It is evaluating MEN1703 both as a standalone treatment (monotherapy) and in combination with another drug called glofitamab[1]. The study aims to assess:

  • The safety and tolerability of MEN1703
  • Its effectiveness against lymphoma (anti-lymphoma activity)
  • How the drug behaves in the body (pharmacokinetics)
  • The impact on patients’ quality of life and symptoms

Dosage and Administration

MEN1703 is taken orally in the form of capsules. The study is exploring different dosing regimens[1]:

  • 150 mg daily for 7 consecutive days in 21-day cycles
  • 125 mg daily for 14 consecutive days in 21-day cycles

The medication is available in 25 mg and 100 mg capsules[1].

Potential Benefits

The primary goals of the study include evaluating[1]:

  • Complete Response (CR) rate: This measures how many patients experience a complete disappearance of all detectable cancer.
  • Overall Response Rate (ORR): This includes both complete and partial responses to the treatment.
  • Duration of Response (DoR): How long the beneficial effects of the treatment last.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

Eligibility Criteria

Key eligibility criteria for participating in the MEN1703 clinical trial include[1]:

  • Age 18 or older
  • Confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma
  • Have received at least 2 prior lines of systemic treatment
  • Adequate organ function and performance status

Patients with certain conditions, such as active central nervous system involvement, recent stem cell transplant, or certain autoimmune diseases, may not be eligible.

Safety Considerations

As with any investigational drug, there may be unknown risks and side effects. The study closely monitors for adverse events. Some areas of particular focus include[1]:

  • Liver function
  • Heart function
  • Blood cell counts
  • Potential drug interactions

Patients in the trial will be closely monitored for any side effects or safety concerns throughout their participation.

Aspect Details
Drug Name MEN1703 (5,6-Dibromo-4-Nitro-2-Piperidin-4-Yl-1-Propan-2-Ylbenzimidazole)
Condition Studied Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Trial Phase Phase II
Treatment Groups 1) MEN1703 + Glofitamab, 2) MEN1703 monotherapy
Dosing Oral capsules, 125-150 mg daily for 7-14 days in 21-day cycles
Primary Objectives Safety, tolerability, and anti-lymphoma activity
Key Eligibility Adults with confirmed diagnosis, ≥2 prior treatments, adequate organ function
Primary Endpoints Adverse events, Complete Response Rate, Overall Response Rate

FAQ

  • What is MEN1703? MEN1703 is a new drug being tested for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Its scientific name is 5,6-Dibromo-4-Nitro-2-Piperidin-4-Yl-1-Propan-2-Ylbenzimidazole.
  • How is MEN1703 administered in the clinical trials? MEN1703 is given orally as capsules. In the trials, it is being tested in different dosing schedules, such as 150 mg daily for 7 consecutive days or 125 mg daily for 14 consecutive days in 21-day treatment cycles.
  • What is the main goal of these clinical trials? The main goals are to evaluate the safety and effectiveness of MEN1703, both as a standalone treatment and in combination with glofitamab, for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
  • Who is eligible to participate in these trials? Eligible participants are adults (18 years or older) with confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who have received at least two prior lines of systemic treatment. They must also meet specific health criteria outlined in the trial protocol.
  • What are the primary outcomes being measured in these trials? The primary outcomes include the incidence and severity of adverse events, complete response rate (for the combination therapy group), and overall response rate (for the monotherapy group), as assessed by an Independent Review Committee.

Ongoing Clinical Trials on 5,6-Dibromo-4-Nitro-2-Piperidin-4-Yl-1-Propan-2-Ylbenzimidazole

  • Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

    Recruiting

    2 1 1 1 1
    Investigated drugs:
    France Poland Spain

Glossary

  • Relapsed or Refractory: In cancer treatment, 'relapsed' means the cancer has returned after a period of improvement, while 'refractory' means the cancer has not responded to treatment or has continued to grow despite treatment.
  • B-cell Non-Hodgkin Lymphoma: A type of cancer that starts in white blood cells called B-lymphocytes, which are part of the body's immune system. It is considered 'aggressive' when it grows and spreads quickly.
  • Monotherapy: Treatment using a single drug or method.
  • Bispecific Antibody: A type of engineered antibody that can recognize and bind to two different targets simultaneously, often used in cancer immunotherapy.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Complete Response (CR): In cancer treatment, this means all signs of cancer have disappeared in response to treatment.
  • Overall 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 with the disease without it worsening.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Independent Review Committee (IRC): A group of experts who independently review and assess the results of a clinical trial to ensure unbiased evaluation.

References

  1. http://clinicaltrials.eu/trial/study-of-men1703-and-glofitamab-for-patients-with-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma/