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Necvax-Neo1

NECVAX-NEO1 is an innovative drug currently being studied in clinical trials for its potential in treating various types of cancer. These trials aim to assess the safety, tolerability, and effectiveness of NECVAX-NEO1 when used in combination with other cancer treatments, particularly immunotherapy drugs known as PD-1 or PD-L1 inhibitors. The studies focus on patients with advanced solid tumors and triple-negative breast cancer, offering hope for new treatment options in challenging cancer cases.

Table of Contents

What is NECVAX-NEO1?

NECVAX-NEO1 is a novel investigational drug being developed by NEC Bio Therapeutics GmbH for the treatment of advanced solid tumors and triple-negative breast cancer (TNBC)[1][2]. It is currently undergoing clinical trials to assess its safety, tolerability, and effectiveness when used in combination with other cancer treatments.

How does NECVAX-NEO1 work?

NECVAX-NEO1 is designed to work in conjunction with immunotherapy drugs known as PD-1 or PD-L1 inhibitors. These inhibitors help the immune system recognize and attack cancer cells. NECVAX-NEO1 is believed to enhance the effectiveness of these immunotherapies, potentially leading to better outcomes for patients[1].

What conditions does NECVAX-NEO1 treat?

NECVAX-NEO1 is being investigated for the treatment of:

  • Advanced solid tumors: These are cancers that form solid masses in various parts of the body and have progressed to an advanced stage[1].
  • Triple-negative breast cancer (TNBC): This is an aggressive type of breast cancer that lacks three common receptors found in other breast cancers, making it more challenging to treat[2].

Current Clinical Trials

Two clinical trials are currently underway to evaluate NECVAX-NEO1:

  1. NECVAX-NEO1-02-INT: This is an open-label, Phase I/II multicenter trial studying NECVAX-NEO1 in combination with PD-1 or PD-L1 inhibitors for patients with advanced solid tumors[1].
  2. NECVAX-NEO1-05-DE: This is an open-label, Phase I/II multicenter trial investigating NECVAX-NEO1 as an add-on to first-line neoadjuvant anti-PD-1 therapy in patients with triple-negative breast cancer[2].
These trials aim to assess the safety, tolerability, and effectiveness of NECVAX-NEO1 when used alongside other cancer treatments.

How is NECVAX-NEO1 administered?

NECVAX-NEO1 is administered as an oral liquid[1]. In some cases, it may also be given through infusion[2]. The exact dosage and administration schedule will depend on the specific clinical trial and the patient’s individual needs.

Who is eligible for NECVAX-NEO1 treatment?

Eligibility criteria for NECVAX-NEO1 treatment in clinical trials typically include:

  • Adults aged 18 years or older
  • Diagnosis of advanced solid tumors or triple-negative breast cancer
  • Adequate organ function (kidney, liver, bone marrow)
  • ECOG performance status of 2 or less (a measure of a patient’s ability to perform daily activities)
  • Life expectancy of at least 6-12 months
Patients with certain medical conditions, such as active infections, autoimmune diseases, or a history of organ transplantation, may not be eligible for these trials[1][2].

Potential Side Effects

As NECVAX-NEO1 is still in clinical trials, the full range of potential side effects is not yet known. The ongoing studies are closely monitoring for adverse events and changes in laboratory parameters, physical examinations, vital signs, and electrocardiograms[1][2]. Patients participating in these trials will be closely monitored for any potential side effects.

Future Research and Potential

The ongoing clinical trials for NECVAX-NEO1 are exploring several important aspects of its potential as a cancer treatment:

  • Its ability to enhance the effectiveness of immunotherapy drugs
  • Its impact on circulating tumor DNA (ctDNA), which can be an indicator of treatment response
  • Its effects on overall survival and progression-free survival in cancer patients
  • Its potential to improve outcomes in difficult-to-treat cancers like triple-negative breast cancer
The results of these trials will help determine the future of NECVAX-NEO1 as a potential new treatment option for cancer patients[1][2].

Aspect Details
Drug Name NECVAX-NEO1
Trial Types Phase I/II, open-label, multicenter
Cancer Types Advanced solid tumors, Triple-negative breast cancer (TNBC)
Combination Therapy Used with PD-1 or PD-L1 inhibitors
Primary Objectives Assess safety and tolerability
Secondary Objectives Evaluate antitumor activity, clinical efficacy, overall survival
Key Measurements Adverse events, laboratory parameters, ctDNA levels, tumor response (RECIST 1.1, iRECIST)
Eligibility Adult patients with specific cancer types, adequate organ function, ability to follow trial instructions
Administration Oral liquid or infusion

FAQ

  • What is NECVAX-NEO1? NECVAX-NEO1 is an experimental drug being tested in clinical trials for cancer treatment. It is designed to work in combination with other cancer therapies, particularly immunotherapy drugs called PD-1 or PD-L1 inhibitors.
  • What types of cancer are being studied with NECVAX-NEO1? The clinical trials are focusing on advanced solid tumors and triple-negative breast cancer. These are challenging types of cancer that often require new treatment approaches.
  • How is NECVAX-NEO1 administered? NECVAX-NEO1 is given as an oral liquid or through infusion, depending on the specific trial protocol.
  • What are the main goals of these clinical trials? The primary goals are to assess the safety and tolerability of NECVAX-NEO1 when used with other cancer treatments. Secondary goals include evaluating its effectiveness in fighting cancer and improving patient survival.
  • Who can participate in these clinical trials? Eligibility varies, but generally includes adult patients with specific types of cancer, adequate organ function, and the ability to understand and follow trial instructions. Detailed criteria are set for each trial to ensure patient safety and study validity.

Ongoing Clinical Trials on Necvax-Neo1

  • Study on NECVAX-NEO1 and Paclitaxel Albumin-Bound for Patients with Triple-Negative Breast Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on NECVAX-NEO1 with PD-1/PD-L1 Inhibitors for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    Germany Lithuania Spain

Glossary

  • PD-1/PD-L1 inhibitors: These are types of immunotherapy drugs that help the immune system recognize and attack cancer cells by blocking proteins called PD-1 or PD-L1.
  • Circulating tumor DNA (ctDNA): Small pieces of DNA from cancer cells that can be found in the blood. Measuring ctDNA can help monitor how well a treatment is working.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure if tumors are shrinking, growing, or staying the same size during treatment.
  • iRECIST: A modified version of RECIST used specifically for evaluating the response to immunotherapy treatments.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually before surgery, to try to shrink the tumor.
  • Triple-negative breast cancer (TNBC): A type of breast cancer that doesn't have receptors for estrogen, progesterone, or HER2 protein, making it harder to treat with standard therapies.
  • Pathological complete response (pCR): When no cancer cells are found in tissue samples after treatment, indicating that the treatment was highly effective.
  • Residual cancer burden (RCB): A measure of how much cancer remains after treatment, used to predict long-term outcomes in breast cancer patients.
  • Event-free survival (EFS): The length of time after treatment that a patient remains free of certain complications or events related to their disease.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-on-necvax-neo1-with-pd-1-pd-l1-inhibitors-for-patients-with-advanced-solid-tumors/
  2. http://clinicaltrials.eu/trial/study-on-necvax-neo1-and-paclitaxel-albumin-bound-for-patients-with-triple-negative-breast-cancer/