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Neob

NeoB is an investigational drug being studied in clinical trials for various advanced solid tumors. It targets a protein called gastrin-releasing peptide receptor (GRPR), which is overexpressed in certain cancers. The trials are evaluating NeoB as both an imaging agent ([68Ga]Ga-NeoB) and a therapeutic agent ([177Lu]Lu-NeoB) to detect and treat GRPR-positive tumors. These studies aim to determine the safety, efficacy, and optimal dosing of NeoB in different cancer types and treatment combinations.

Table of Contents

What is NEOB?

NEOB is a new drug being studied for its potential in treating various types of cancer. It is known by several names, including [177Lu]Lu-NeoB, [68Ga]Ga-NeoB, Lu-NeoB, and Ga-NeoB, depending on the specific form and use[1][3]. NEOB belongs to a class of drugs called radioligand therapies, which use radioactive substances to target and treat cancer cells[5].

How NEOB Works

NEOB works by targeting a specific protein called the Gastrin-Releasing Peptide Receptor (GRPR), which is found in high amounts on the surface of certain cancer cells[1]. The drug is designed to attach to these receptors and deliver a dose of radiation directly to the cancer cells, potentially killing them or slowing their growth while minimizing damage to healthy tissues[5].

Conditions Treated with NEOB

NEOB is being investigated for use in several types of cancer, including:

  • Breast cancer: Particularly in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other parts of the body (metastatic)[5][4]
  • Prostate cancer: Including advanced prostate cancer and a rare, aggressive form called neuroendocrine prostate cancer[1][6]
  • Lung cancer[1]
  • Gastrointestinal stromal tumors (GIST)[1]
  • Glioblastoma: An aggressive type of brain cancer[3]

Clinical Trials Involving NEOB

Several clinical trials are currently underway to evaluate the safety and effectiveness of NEOB:

  • A phase I/IIa study is testing NEOB in patients with various advanced solid tumors[1]
  • A phase Ib study is investigating NEOB in combination with other drugs (ribociclib and fulvestrant) for breast cancer[5]
  • A phase Ib study is exploring NEOB’s use in newly diagnosed and recurrent glioblastoma[3]
  • A pilot study is assessing NEOB as an imaging tool for breast cancer staging[4]
  • A phase I study is evaluating NEOB alongside other targeted therapies for neuroendocrine prostate cancer[6]

How NEOB is Administered

NEOB is typically administered in two forms:

  1. [68Ga]Ga-NeoB: This form is used for imaging purposes. It’s given as an intravenous injection before a PET (Positron Emission Tomography) scan to help locate cancer cells in the body[4].
  2. [177Lu]Lu-NeoB: This is the treatment form of the drug. It’s usually given as an intravenous infusion every 3 to 6 weeks, depending on the specific trial and condition being treated[5][3].

Safety and Side Effects

As NEOB is still in clinical trials, its full safety profile is not yet established. Researchers are closely monitoring patients for potential side effects, which may include:

  • Fatigue
  • Nausea
  • Changes in blood cell counts
  • Effects on kidney function

The trials are designed to determine the safest and most effective dose of NEOB, as well as to identify any potential side effects[1][5].

Future Prospects for NEOB

NEOB shows promise as a targeted therapy for various types of cancer, particularly those that express high levels of GRPR. If successful in clinical trials, it could offer a new treatment option for patients who have not responded well to other therapies or whose cancer has returned after previous treatments[5][6].

Researchers are also exploring the use of NEOB as a diagnostic tool. The [68Ga]Ga-NeoB form could potentially help doctors more accurately locate and stage cancers, leading to better treatment planning[4].

As research continues, we may learn more about how NEOB can be used effectively, either alone or in combination with other cancer treatments, to improve outcomes for patients with various types of cancer.

Aspect Details
Drug Name NeoB (imaging: [68Ga]Ga-NeoB, therapy: [177Lu]Lu-NeoB)
Target Gastrin-releasing peptide receptor (GRPR)
Cancer Types Advanced solid tumors including breast, prostate, glioblastoma, neuroendocrine prostate cancer
Trial Phases Phase I/II
Administration Intravenous infusion
Key Objectives Safety, tolerability, optimal dosing, efficacy, pharmacokinetics
Outcome Measures Dose-limiting toxicities, adverse events, tumor response, progression-free survival, overall survival
Combination Therapies Studied with standard treatments (e.g., radiotherapy, temozolomide, ribociclib, fulvestrant)
Imaging Applications PET/CT or PET/MRI for tumor detection and treatment monitoring
Follow-up Duration Varies by trial, ranging from 17 months to 5 years

FAQ

  • What types of cancer is NeoB being studied for? NeoB is being investigated for several types of advanced solid tumors, including breast cancer, prostate cancer, glioblastoma, and neuroendocrine prostate cancer. It's being studied in cancers known to overexpress the gastrin-releasing peptide receptor (GRPR).
  • How is NeoB administered to patients? NeoB is given as an intravenous (IV) infusion. The imaging agent [68Ga]Ga-NeoB is typically given as a single dose for PET scans. The therapeutic agent [177Lu]Lu-NeoB is usually given in multiple cycles, often every 3-6 weeks, depending on the specific trial protocol.
  • What are the main goals of the NeoB clinical trials? The main goals include assessing the safety and tolerability of NeoB, determining the optimal dose, evaluating its effectiveness in treating tumors, and studying how the drug is distributed and processed in the body (pharmacokinetics). Some trials are also comparing NeoB imaging to conventional imaging methods.
  • Are there any side effects associated with NeoB? As with any investigational drug, potential side effects are being closely monitored in the clinical trials. The studies are tracking adverse events and serious adverse events. Specific side effects information is not provided in the trial summaries, as this data is still being collected and analyzed.
  • How long do the NeoB clinical trials last? The duration varies depending on the specific trial. Some studies last up to 17 months, while others follow patients for up to 5 years after treatment. The treatment period itself typically ranges from a few months to about a year, followed by longer-term follow-up to monitor for safety and disease progression.

Ongoing Clinical Trials on Neob

  • Study of [177Lu]Lu-NeoB and Capecitabine for Patients with Advanced Breast Cancer Resistant to Hormone Therapy

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Germany Italy The Netherlands Portugal Spain

  • Study on the Safety and Effects of [177Lu]-NeoB in Patients with Advanced Solid Tumors Overexpressing GRPR

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France The Netherlands Spain

Glossary

  • Gastrin-releasing peptide receptor (GRPR): A protein found on the surface of some cancer cells that is targeted by NeoB. It is overexpressed in certain types of tumors.
  • [68Ga]Ga-NeoB: A radioactive imaging agent used in PET scans to detect tumors that express GRPR. It helps locate and measure the extent of cancer in the body.
  • [177Lu]Lu-NeoB: A radioactive therapeutic agent designed to deliver targeted radiation to GRPR-expressing tumor cells, potentially killing the cancer cells.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent increasing the dose of a drug in a clinical trial. DLTs help determine the maximum tolerated dose.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It includes complete responses and partial responses.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment based on changes in tumor size.
  • Theranostics: An approach that combines diagnostics and therapy, using the same molecule for both imaging and treatment of a disease.

References

  1. https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-177lu-neob-in-patients-with-advanced-solid-tumors-overexpressing-grpr/
  2. https://clinicaltrials.gov/study/NCT06247995
  3. https://clinicaltrials.gov/study/NCT05739942
  4. https://clinicaltrials.gov/study/NCT05889728
  5. https://clinicaltrials.gov/study/NCT05870579
  6. https://clinicaltrials.gov/study/NCT06379217