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Budigalimab

Budigalimab, also known as ABBV-181, is an investigational drug being studied in clinical trials for the treatment of various conditions, including HIV, solid tumors, and specific types of cancer. This article provides an overview of the ongoing research into Budigalimab’s safety, efficacy, and potential applications in different therapeutic areas.

Table of Contents

What is Budigalimab?

Budigalimab, also known as ABBV-181, is an investigational drug being developed by pharmaceutical companies to treat various types of cancers and HIV (Human Immunodeficiency Virus) infection[1][2]. An investigational drug is a medication that is still being studied and has not yet been approved for general use by health authorities. Budigalimab is currently undergoing clinical trials to evaluate its safety and effectiveness in treating different medical conditions.

How Budigalimab Works

Budigalimab is a type of drug called an immune checkpoint inhibitor. It works by helping the body’s immune system to fight against cancer cells or viruses more effectively[3]. Specifically, Budigalimab targets a protein called PD-1 (Programmed Cell Death protein 1) that is found on certain immune cells. By blocking PD-1, Budigalimab helps to “take the brakes off” the immune system, allowing it to recognize and attack cancer cells or infected cells more efficiently.

Conditions Treated with Budigalimab

Budigalimab is being studied for the treatment of several medical conditions, including:

  • HIV (Human Immunodeficiency Virus): Budigalimab is being tested as a potential treatment for people living with HIV, with the aim of controlling the virus and potentially reducing the need for lifelong antiretroviral therapy[1][2].
  • Hepatocellular Carcinoma (HCC): This is a type of liver cancer. Budigalimab is being studied in combination with other drugs for treating advanced or metastatic HCC[4][5].
  • Non-Small Cell Lung Cancer (NSCLC): Budigalimab is being investigated for the treatment of this common type of lung cancer[3].
  • Head and Neck Squamous Cell Carcinoma (HNSCC): This is a type of cancer that affects the mouth, nose, and throat areas[3].
  • Small Cell Lung Cancer (SCLC): Budigalimab is being tested in combination with other drugs for this aggressive form of lung cancer[6].
  • Other solid tumors: Various other types of solid tumors are also being studied in clinical trials involving Budigalimab[7].

How Budigalimab is Administered

Budigalimab is typically administered to patients in the following ways:

  • Intravenous (IV) infusion: This is the most common method, where the drug is given directly into a vein through a needle or catheter[1].
  • Subcutaneous (SC) injection: In some studies, Budigalimab is also being tested as an injection under the skin[2].

The dosage and frequency of administration can vary depending on the specific condition being treated and the clinical trial protocol. In many studies, Budigalimab is given every 3 or 4 weeks[5].

Budigalimab in Clinical Trials

Budigalimab is currently being studied in various clinical trials, which are research studies that test how well new medical approaches work in people. These trials are evaluating:

  • Safety: Researchers are closely monitoring for any side effects or adverse events that may occur when taking Budigalimab[1].
  • Efficacy: The trials are measuring how well Budigalimab works in treating different conditions, often by looking at factors like tumor shrinkage, virus control, or overall survival[5].
  • Dosing: Different doses of Budigalimab are being tested to find the most effective and safe amount[8].
  • Combinations: Budigalimab is often studied in combination with other drugs to see if they work better together than alone[4].

Potential Side Effects

As with any medication, Budigalimab may cause side effects. In clinical trials, researchers are carefully monitoring for adverse events, which can include:

  • Immune-related adverse events: Because Budigalimab affects the immune system, it can sometimes cause the immune system to attack healthy parts of the body[1].
  • Fatigue: Feeling very tired is a common side effect of many cancer treatments.
  • Nausea or vomiting: Some patients may experience stomach upset.
  • Skin reactions: Rashes or itching can occur in some patients.

It’s important to note that not all patients will experience these side effects, and the severity can vary. In clinical trials, doctors closely monitor patients and can adjust treatment if needed.

Future Prospects for Budigalimab

The ongoing clinical trials for Budigalimab are helping researchers understand more about its potential benefits and risks. If the results of these trials are positive, Budigalimab could become an important new treatment option for various types of cancer and HIV in the future[2][5].

However, it’s important to remember that as an investigational drug, Budigalimab is not yet approved for general use. Patients interested in this treatment should discuss with their healthcare providers about the possibility of participating in clinical trials or other available treatment options.

Aspect Details
Drug Name Budigalimab (ABBV-181)
Administration Methods Intravenous (IV) infusion, Subcutaneous (SC) injection
Conditions Studied HIV, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Hepatocellular carcinoma (HCC), Small cell lung cancer (SCLC), Advanced solid tumors
Study Types Phase 1, Phase 1b, Phase 2 clinical trials
Primary Outcomes Safety (adverse events), Efficacy (objective response rate, progression-free survival), Pharmacokinetics
Combination Therapies Livmoniplimab (ABBV-151), ABBV-514, ABBV-706, Carboplatin, Cisplatin
Key Measurements Maximum serum concentration (Cmax), Area under the curve (AUC), Time to maximum concentration (Tmax), Anti-drug antibodies (ADA)

FAQ

  • What is Budigalimab? Budigalimab, also known as ABBV-181, is an investigational drug being studied for the treatment of various conditions, including HIV, solid tumors, and specific types of cancer. It is typically administered through intravenous (IV) infusion or subcutaneous (SC) injection.
  • What conditions is Budigalimab being studied for? Budigalimab is being investigated for multiple conditions, including HIV, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and other advanced solid tumors.
  • How is Budigalimab administered in clinical trials? In clinical trials, Budigalimab is typically administered through intravenous (IV) infusion or subcutaneous (SC) injection. The dosing regimens and frequencies vary depending on the specific study and condition being treated.
  • What are the main outcomes being measured in Budigalimab clinical trials? The main outcomes being measured in Budigalimab clinical trials include safety (adverse events), efficacy (such as objective response rate, progression-free survival, and overall survival), pharmacokinetics (how the drug moves through the body), and the development of anti-drug antibodies.
  • Is Budigalimab being studied alone or in combination with other treatments? Budigalimab is being studied both as a monotherapy and in combination with other treatments. Some trials are investigating its use in combination with other investigational drugs (like ABBV-151, ABBV-514, or ABBV-706), while others are studying it in combination with established cancer treatments like chemotherapy drugs (carboplatin or cisplatin).

Ongoing Clinical Trials on Budigalimab

  • Study of ABBV-400 and Budigalimab for Adults with Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Romania +1

  • Study on ABBV-400, Fluorouracil, Leucovorin, and Budigalimab for Advanced or Metastatic Stomach and Esophageal Cancer Patients

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium Germany Spain

  • Study on Advanced Liver Cancer: Evaluating Livmoniplimab and Budigalimab in Patients Without Prior Systemic Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on Livmoniplimab and Budigalimab with Chemotherapy for Adults with Untreated Metastatic Non-Small Cell Lung Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France The Netherlands Spain

  • Study of Livmoniplimab and Budigalimab Compared to Chemotherapy for Adults with Advanced Bladder Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Poland Spain

  • Study on the Safety and Effects of Livmoniplimab and Budigalimab in Patients with Advanced or Metastatic Solid Tumors

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy Poland Spain

  • Study on Budigalimab and ABBV-382 for People with HIV on Stable Antiretroviral Therapy

    Not recruiting

    1
    Investigated drugs:
    Belgium Denmark France Germany Italy Poland +1

  • Study on TTX-030, Budigalimab, and Chemotherapy for Untreated Metastatic Pancreatic Cancer Patients

    Not recruiting

    1 1 1
    Investigated drugs:
    Czechia France Italy Spain

  • Study on Hepatocellular Carcinoma: Evaluating Livmoniplimab and Budigalimab for Patients with Advanced or Metastatic Cancer After First-Line Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

Glossary

  • Budigalimab: An investigational drug, also known as ABBV-181, being studied for the treatment of various conditions including HIV and different types of cancer.
  • Intravenous (IV) infusion: A method of administering medication directly into a vein using a needle or catheter.
  • Subcutaneous (SC) injection: A method of administering medication into the layer of tissue between the skin and muscle.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse event (AE): Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment.
  • Maximum tolerated dose (MTD): The highest dose of a drug or treatment that does not cause unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined to be appropriate for further testing in Phase 2 clinical trials based on safety and efficacy data from earlier studies.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Anti-drug antibodies (ADA): Antibodies produced by the body's immune system in response to a therapeutic drug, which may affect the drug's efficacy or safety.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.
  • Analytical Treatment Interruption (ATI): A planned pause in antiretroviral therapy for HIV patients to assess the effects of an experimental treatment on viral control.

References

  1. https://clinicaltrials.gov/study/NCT04799353
  2. https://clinicaltrials.eu/trial/study-on-budigalimab-and-abbv-382-for-people-with-hiv-on-stable-antiretroviral-therapy/
  3. https://clinicaltrials.gov/study/NCT05005403
  4. https://clinicaltrials.gov/study/NCT06487559
  5. https://clinicaltrials.gov/study/NCT05822752
  6. https://clinicaltrials.gov/study/NCT03639194
  7. https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-livmoniplimab-and-budigalimab-in-patients-with-advanced-or-metastatic-solid-tumors/
  8. https://clinicaltrials.gov/study/NCT06628310