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Humanised Bispecific Immunoglobulin Vhh Fragments Against Psma And Vgamma9Vdelta2 T-Cell Receptor

This article discusses the clinical trials of LAVA-1207, a new drug designed to treat advanced prostate cancer that has become resistant to other therapies. LAVA-1207 is a bispecific immunotherapy that targets specific proteins on cancer cells and activates the body’s immune system to fight the disease. The trials aim to evaluate the safety, effectiveness, and potential benefits of this innovative treatment approach for patients with metastatic castration-resistant prostate cancer.

Table of Contents

What is LAVA-1207?

LAVA-1207 is a new experimental drug being developed for the treatment of advanced prostate cancer. Its full scientific name is “humanised bispecific immunoglobulin VHH fragments against PSMA and Vgamma9Vdelta2 T-cell receptor”[1]. This complex name describes the drug’s unique structure and how it works in the body.

The drug is also known by its simpler name, LAVA-1207, which is easier for patients and doctors to use in everyday conversations[1].

How does LAVA-1207 work?

LAVA-1207 is a type of drug called a bispecific γδ-T cell engager[1]. This means it can bind to two different things at once:

  1. It attaches to a protein called PSMA (Prostate-Specific Membrane Antigen), which is found on prostate cancer cells.
  2. It also binds to a specific type of immune cell in your body called Vgamma9Vdelta2 T-cells.

By connecting these two, LAVA-1207 helps your immune system find and attack the cancer cells more effectively. This approach is part of a field called immunotherapy, which uses your body’s own defense mechanisms to fight cancer.

What conditions does LAVA-1207 treat?

LAVA-1207 is being developed to treat metastatic castration-resistant prostate cancer (mCRPC)[1]. Let’s break down what this means:

  • Metastatic: The cancer has spread from the prostate to other parts of the body.
  • Castration-resistant: The cancer continues to grow even when the levels of male hormones (like testosterone) are reduced to very low levels.
  • Prostate cancer: A type of cancer that begins in the prostate gland, which is part of the male reproductive system.

This form of prostate cancer is particularly challenging to treat because it has become resistant to standard hormone therapies.

Current Clinical Trial

LAVA-1207 is currently being tested in a clinical trial called LAVA1207-001/LAVA1207-002[1]. This is a Phase 1 and 2a trial, which means it’s in the early stages of testing in humans. The main goals of this trial are to:

  • Check if LAVA-1207 is safe to use in patients
  • See how well patients tolerate the drug
  • Understand how the drug moves through and acts in the body
  • Look for early signs that the drug might be working against the cancer

Who can participate in the trial?

The trial is looking for men with advanced prostate cancer who meet specific criteria[1]. Some key points include:

  • Must be 18 years or older
  • Have metastatic castration-resistant prostate cancer
  • Have tried at least one type of chemotherapy (or be unable to receive chemotherapy)
  • Have tried at least one newer type of hormone therapy
  • Have evidence that their cancer is still growing despite previous treatments

There are also several factors that might prevent someone from participating, such as having certain other medical conditions or infections.

What to expect during the trial

The trial is testing LAVA-1207 in three different ways[1]:

  1. LAVA-1207 alone: Some patients will receive just LAVA-1207.
  2. LAVA-1207 with low-dose IL-2: Some patients will receive LAVA-1207 plus a low dose of another drug called interleukin-2, which can help boost the immune system.
  3. LAVA-1207 with pembrolizumab: Some patients will receive LAVA-1207 plus another immunotherapy drug called pembrolizumab.

Patients will receive LAVA-1207 through an infusion (a slow injection into a vein). The treatment will continue for about 24 weeks, or until the cancer progresses or side effects become too severe[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to participating in this trial:

Potential benefits:

  • Access to a new treatment that might be effective against advanced prostate cancer
  • Close monitoring by a team of medical professionals
  • Contributing to the advancement of cancer research

Potential risks:

  • Unknown side effects, as this is an early-stage trial
  • The treatment may not be effective for everyone
  • Time commitment for medical visits and procedures

It’s important to discuss these potential benefits and risks thoroughly with your doctor before deciding to participate in any clinical trial.

Aspect Details
Drug Name LAVA-1207
Drug Type Bispecific immunotherapy (PSMA-targeting γδ-T cell engager)
Target Condition Metastatic castration-resistant prostate cancer (mCRPC)
Trial Phase Phase 1 and 2a
Trial Design Open-label, dose escalation and expansion
Treatment Arms 1. LAVA-1207 alone
2. LAVA-1207 + low-dose IL-2
3. LAVA-1207 + pembrolizumab
Primary Objectives Safety, tolerability, and determining recommended Phase 2 dose
Secondary Objectives Antitumor activity, pharmacokinetics, pharmacodynamics, immunogenicity
Key Eligibility Criteria Adult males with mCRPC, prior taxane-based chemotherapy, progression on hormone therapy
Treatment Duration Approximately 24 weeks or until disease progression/unacceptable toxicity

FAQ

  • What is LAVA-1207 and how does it work? LAVA-1207 is a bispecific immunotherapy drug that targets PSMA (a protein found on prostate cancer cells) and activates gamma-delta T cells (a type of immune cell). It's designed to help the immune system recognize and attack prostate cancer cells more effectively.
  • Who is eligible for the LAVA-1207 clinical trials? The trials are for adult men with metastatic castration-resistant prostate cancer who have tried at least one chemotherapy treatment and hormone therapy. Patients must have progressive disease and meet specific health criteria.
  • What are the main goals of the LAVA-1207 clinical trials? The main goals are to assess the safety and tolerability of LAVA-1207, determine the right dose, and evaluate its effectiveness in treating advanced prostate cancer. The trials also aim to study how the drug behaves in the body and its effects on the immune system.
  • How is LAVA-1207 administered in the clinical trials? LAVA-1207 is given as a solution for infusion, which means it's delivered directly into the bloodstream through an IV. Some patients may receive LAVA-1207 alone, while others may receive it in combination with low-dose interleukin-2 or pembrolizumab.
  • How long do patients receive treatment in the LAVA-1207 trials? Patients typically receive LAVA-1207 for about 24 weeks or until their disease progresses, they experience unacceptable side effects, or they choose to withdraw from the study. The exact duration may vary depending on individual patient responses and the specific trial protocol.

Ongoing Clinical Trials on Humanised Bispecific Immunoglobulin Vhh Fragments Against Psma And Vgamma9Vdelta2 T-Cell Receptor

  • Study on LAVA-1207 and Pembrolizumab for Patients with Advanced Prostate Cancer Resistant to Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Spain

Glossary

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC): An advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy that lowers testosterone levels.
  • Bispecific Immunotherapy: A type of treatment that uses specially designed molecules to target two different proteins simultaneously, often one on cancer cells and another on immune cells, to enhance the immune system's ability to fight cancer.
  • PSMA (Prostate-Specific Membrane Antigen): A protein found on the surface of prostate cancer cells, which can be targeted by certain drugs or imaging techniques.
  • Gamma-delta T cells: A specific type of immune cell that can recognize and attack cancer cells. LAVA-1207 is designed to activate these cells to fight prostate cancer.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Pharmacodynamics: The study of a drug's effects on the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body. In clinical trials, this is monitored to ensure the treatment doesn't cause harmful immune reactions.
  • Antitumor Activity: The ability of a treatment to stop the growth of or shrink tumors.
  • Dose Escalation: A method used in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • RP2D (Recommended Phase 2 Dose): The dose of a drug determined to be safe and potentially effective, which is then used in further phases of clinical trials.
  • RECIST (Response Evaluation Criteria in Solid Tumors): A set of rules used to measure how well a cancer patient responds to treatment by assessing changes in tumor size.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • CTCAE (Common Terminology Criteria for Adverse Events): A standardized system for classifying the severity of side effects in cancer therapy clinical trials.
  • CRS (Cytokine Release Syndrome): A condition that can occur as a side effect of certain immunotherapies, causing symptoms like fever, nausea, and headache due to an overactive immune response.

References

  1. http://clinicaltrials.eu/trial/study-on-lava-1207-and-pembrolizumab-for-patients-with-advanced-prostate-cancer-resistant-to-treatment/