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Iph6501

A groundbreaking clinical trial is underway to investigate the potential of IPH6501, a new drug designed to treat patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma. This international, first-in-human study aims to evaluate the safety, tolerability, and preliminary effectiveness of IPH6501 in patients who have not responded well to previous treatments. The trial consists of two phases: a dose-finding phase and a dose expansion phase, offering hope for those battling this challenging form of cancer.

Table of Contents

What is IPH6501?

IPH6501 is a new drug currently being studied for the treatment of certain types of blood cancers. It’s specifically designed to target CD20-expressing Non-Hodgkin Lymphoma, a group of blood cancers that affect white blood cells called lymphocytes.[1]

What condition does IPH6501 target?

IPH6501 is being developed to treat B-Cell Non-Hodgkin Lymphoma (NHL). This is a type of cancer that starts in white blood cells called B-lymphocytes, which are an important part of the immune system. The drug is specifically designed for patients whose lymphoma has either come back after treatment (relapsed) or hasn’t responded well to previous treatments (refractory).[1]

Current Clinical Trial

IPH6501 is currently being tested in a clinical trial. This trial is described as an “international, first-in-human, multicenter, open-label Phase 1/2 study”. Let’s break down what this means:

  • International and multicenter: The study is being conducted in multiple countries and at multiple medical centers.
  • First-in-human: This is the first time the drug is being tested in human subjects.
  • Open-label: Both the researchers and the patients know which treatment is being given.
  • Phase 1/2: This combines the first two phases of clinical trials, which focus on safety, dosing, and early signs of effectiveness.

Objectives of the Clinical Trial

The main goals of this clinical trial are:

  1. To evaluate the safety profile of IPH6501
  2. To determine how well patients tolerate the drug
  3. To find the right dose for future studies (called the “recommended phase 2 dose” or RP2D)[1]

Phases of the Clinical Trial

The trial is divided into two main phases:

Phase 1 – Dose Finding

This phase includes patients with advanced, confirmed CD20+ B-cell NHL. It has two parts:

  1. Dose escalation: This part aims to find the highest dose that doesn’t cause unacceptable side effects (called the Maximum Tolerated Dose or MTD).
  2. Dose assessment: This part will determine the recommended dose for Phase 2 (RP2D).[1]

Phase 2 – Dose Expansion

In this phase, one or more groups of patients with specific subtypes of advanced CD20+ B-cell NHL will receive the dose determined in Phase 1.[1]

Safety and Efficacy Measures

The trial will measure several outcomes to assess both the safety and effectiveness of IPH6501:

  • Safety and tolerability: This is the primary focus, monitored throughout the study period of up to 22 months.
  • Objective Response Rate (ORR): This measures how many patients have a significant reduction in their cancer.
  • Duration of Response (DoR): This looks at how long the positive effects of the treatment last.
  • Progression Free Survival (PFS): This measures how long patients live without their cancer getting worse.[1]

Pharmacokinetics and Immunogenicity

The study will also look at how IPH6501 behaves in the body:

  • Pharmacokinetics: This includes measuring the maximum concentration of the drug in the blood (Cmax) and the total exposure over time (AUC).
  • Immunogenicity: The study will check if patients develop antibodies against IPH6501, which could potentially affect its effectiveness.[1]
Aspect Details
Study Type Phase 1/2, open-label, multicenter trial
Drug IPH6501
Target Condition Relapsed/Refractory CD20+ B-cell Non-Hodgkin Lymphoma
Primary Objective Evaluate safety, tolerability, and determine recommended Phase 2 dose
Secondary Objectives Investigate preliminary antitumor activity, evaluate pharmacokinetics and immunogenicity
Study Duration Up to 22 months (including treatment and follow-up)
Key Outcomes Safety profile, Objective Response Rate, Duration of Response, Progression Free Survival

FAQ

  • What is IPH6501? IPH6501 is a new drug being studied for the treatment of relapsed or refractory B-Cell Non-Hodgkin Lymphoma. It is designed to target CD20-expressing lymphoma cells.
  • What is the main goal of this clinical trial? The main goal is to evaluate the safety profile and tolerability of IPH6501, and to determine the recommended dose for future Phase 2 studies in patients with B-Cell Non-Hodgkin Lymphoma.
  • How is the trial structured? The trial is divided into two phases: Phase 1 (dose finding) and Phase 2 (dose expansion). Phase 1 includes dose escalation to determine the Maximum Tolerated Dose and dose assessment to determine the recommended Phase 2 dose.
  • What outcomes will be measured in this trial? The trial will measure safety and tolerability as primary outcomes. Secondary outcomes include Objective Response Rate, Duration of Response, Progression Free Survival, and pharmacokinetic measures like Maximum Observed Plasma Concentration and Area Under the Plasma Concentration.
  • How long will participants be followed in this study? Participants will be followed for up to 22 months, from the time of informed consent through the treatment period and including the follow-up phase.

Ongoing Clinical Trials on Iph6501

  • Study on the Safety and Effects of IPH6501 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Non-Hodgkin Lymphoma (NHL): A type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.
  • CD20: A protein found on the surface of B cells, including some types of lymphoma cells. It is often targeted in lymphoma treatments.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined to be safe and potentially effective, which is then used in further studies.
  • 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 the disease without it getting worse.
  • Pharmacokinetic profile: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Antidrug antibodies (ADA): Antibodies produced by the body's immune system against a therapeutic drug, which can potentially reduce the drug's effectiveness.

References