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Ima402

A groundbreaking clinical trial is underway to assess the potential of IMA402, a new bispecific T cell-engaging receptor molecule (TCER®), in treating patients with recurrent and/or refractory solid tumors. This Phase I/II study aims to determine the safety, tolerability, and anti-tumor activity of IMA402, offering hope for patients who have exhausted standard treatment options.

Table of Contents

What is IMA402?

IMA402 is a new medication being developed to treat certain types of advanced cancers[1]. It is classified as a bispecific T cell-engaging receptor molecule (TCER®), which is a type of protein designed to help your immune system fight cancer cells[1]. IMA402 is given as a solution for intravenous infusion, meaning it is administered directly into your bloodstream through a vein[1].

How Does IMA402 Work?

IMA402 works by targeting a specific protein called PRAME (PReferentially expressed Antigen in MElanoma) that is found on many types of cancer cells[1]. By binding to PRAME, IMA402 helps your body’s immune cells, particularly T cells, to recognize and attack the cancer cells. This approach is part of a growing field of cancer treatment called immunotherapy, which aims to boost your body’s natural defenses against cancer[1].

What Conditions Does IMA402 Treat?

IMA402 is being studied for the treatment of recurrent and/or refractory solid tumors[1]. This means it’s intended for patients whose cancer:

  • Has come back after previous treatment (recurrent)
  • Has not responded well to standard treatments (refractory)
The clinical trial is focusing on patients with advanced and/or metastatic solid tumors, which are cancers that form solid masses and may have spread to other parts of the body[1].

Clinical Trial Information

IMA402 is currently being tested in a Phase I/II clinical trial[1]. This means it’s in the early stages of human testing. The trial is divided into several parts:

  1. Phase Ia (Dose Escalation): This part aims to find the safest and most effective dose of IMA402[1].
  2. Phase Ib (Dose Extension): This part will further test the safety and initial effectiveness of IMA402 at the doses determined in Phase Ia[1].
  3. Phase II: This part will test IMA402 in specific types of cancer to see how well it works[1].
The main goals of the trial are to determine the safety of IMA402, find the right dose, and see how well it works against cancer[1].

Eligibility Criteria

To participate in the IMA402 clinical trial, patients must meet certain criteria[1]. Some key requirements include:

  • Being 18 years or older
  • Having a confirmed advanced solid tumor with PRAME expression
  • Having measurable disease according to specific criteria (RECIST 1.1)
  • Being in relatively good overall health (ECOG Performance Status of 0 to 1)
There are also factors that may prevent participation, such as:
  • Having other active cancers requiring treatment
  • Being pregnant or breastfeeding
  • Having active brain metastases (cancer that has spread to the brain)
A doctor involved in the trial can provide more detailed information about eligibility[1].

Potential Benefits and Risks

As IMA402 is still in early testing, its full benefits and risks are not yet known. The clinical trial aims to gather this information[1]. Potential benefits may include shrinking tumors or slowing cancer growth. However, as with any new treatment, there may be unexpected side effects or risks. The trial will closely monitor patients for any side effects, particularly for what are called “dose-limiting toxicities” – side effects severe enough to limit the dose that can be given[1]. It’s important to discuss the potential risks and benefits with your doctor and the clinical trial team before considering participation in this or any clinical trial[1].

Aspect Details
Drug Name IMA402
Drug Type Bispecific T Cell-Engaging Receptor Molecule (TCER®)
Target PRAME in solid tumors
Trial Phase Phase I/II
Patient Population Adults with recurrent and/or refractory solid tumors
Main Objectives Determine MTD/RDEs, assess safety and tolerability, evaluate anti-tumor activity
Trial Structure Phase Ia (dose escalation), Phase Ib (dose extension), Phase II (indication-specific cohorts)
Primary Endpoints Dose-limiting toxicities, adverse events, dose adjustments, objective response rate

FAQ

  • What is IMA402? IMA402 is a bispecific T cell-engaging receptor molecule (TCER®) that targets PRAME, a protein found in certain cancer cells. It's being studied as a potential treatment for patients with recurrent and/or refractory solid tumors.
  • Who is eligible for this clinical trial? Eligible participants are adults (18 years or older) with advanced and/or metastatic solid tumors that have a specific PRAME tumor target expression. They must have measurable disease and have either received or not be eligible for all available standard treatments.
  • What are the main goals of this clinical trial? The main objectives are to determine the maximum tolerated dose of IMA402, characterize its safety and tolerability, and evaluate its anti-tumor activity in patients with recurrent and/or refractory solid tumors.
  • How is the trial structured? The trial is divided into three phases: Phase Ia (dose escalation/de-escalation), Phase Ib (dose extension), and Phase II (indication-specific extension cohorts). This structure allows researchers to carefully assess the drug's effects and determine the best dosing strategy.
  • What are the primary endpoints of the study? The primary endpoints include measuring the number of patients with dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events. The study will also track dose interruptions, reductions, and discontinuations, as well as the objective response rate in Phase II.

Ongoing Clinical Trials on Ima402

  • Study on the Safety and Effectiveness of IMA402, Tocilizumab, and Human Serum Albumin for Patients with Recurrent or Resistant Solid Tumors

    Recruiting

    2 1 1 1
    Investigated drugs:
    Germany The Netherlands

Glossary

  • TCER®: T Cell-Engaging Receptor molecule, a type of bispecific antibody designed to engage T cells to target and attack cancer cells.
  • PRAME: A protein found in certain cancer cells that IMA402 is designed to target.
  • Recurrent tumor: A tumor that has returned after a period of time during which the cancer could not be detected.
  • Refractory tumor: A tumor that does not respond to treatment or stops responding after initial improvement.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Recommended Doses for Extensions (RDEs): The doses of the drug recommended for further study based on safety and initial effectiveness data.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Dose-limiting toxicity: Side effects that are severe enough to prevent an increase in the dose of a drug during a clinical trial.
  • Treatment-emergent adverse events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that appears or worsens after starting the treatment being studied.
  • Objective response rate: The proportion of patients whose cancer shrinks or disappears after treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-ima402-tocilizumab-and-human-serum-albumin-for-patients-with-recurrent-or-resistant-solid-tumors/