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5-Bromopyridin-3-Yl 3-Deoxy-1-Thio-3-[4-(3,4,5-Trifluorophenyl)-1H-1,2,3-Triazol-1-Yl]-Alfa-D-Galactopyranoside

This article discusses the ongoing clinical trials of GB1211, a new drug being tested in combination with atezolizumab for the treatment of Non-Small Cell Lung Cancer (NSCLC). GB1211 is a galectin-3 inhibitor that shows promise in improving the effectiveness of immunotherapy for NSCLC patients. The trials aim to assess the safety, tolerability, and efficacy of this combination therapy in patients with advanced or metastatic NSCLC.

Table of Contents

What is GB1211?

GB1211 is a new drug being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC). Its full scientific name is 5-bromopyridin-3-yl 3-deoxy-1-thio-3-[4-(3,4,5-trifluorophenyl)-1H-1,2,3-triazol-1-yl]-alfa-D-galactopyranoside[1]. This medication comes in the form of a hard capsule that is taken by mouth[1].

How Does GB1211 Work?

GB1211 is classified as a galectin-3 inhibitor. Galectin-3 is a protein that plays a role in cancer growth and spread. By inhibiting or blocking this protein, GB1211 may help slow down or stop the progression of lung cancer[1].

In the current study, GB1211 is being tested in combination with another drug called atezolizumab. Atezolizumab is an immunotherapy drug that helps the body’s immune system recognize and fight cancer cells[1].

Current Research on GB1211

A clinical trial is currently underway to investigate the safety and effectiveness of GB1211 in combination with atezolizumab for patients with Non-Small Cell Lung Cancer[1]. This study is considered a Phase I and Phase II integrated trial, which means it will look at both the safety of the drug and how well it works[1].

The main goals of this study are:

  • To assess the safety and tolerability of GB1211 when used with atezolizumab[1]
  • To determine the best dose of GB1211 to use with atezolizumab[1]
  • To evaluate how effective GB1211 is in treating NSCLC when combined with atezolizumab[1]

Who Can Participate in the GB1211 Study?

The study is looking for patients with specific characteristics, including:

  • Adults 18 years or older[1]
  • Diagnosed with NSCLC stage IIIB or IV[1]
  • Cancer that can be measured using specific criteria (RECIST v1.1)[1]
  • Cancer cells that express a certain level of a protein called PD-L1[1]
  • Have not received prior chemotherapy for advanced or metastatic disease[1]
  • Have not previously received immune checkpoint inhibitors[1]

There are also several conditions that would prevent someone from participating in the study, such as certain heart conditions, autoimmune diseases, or other cancers[1].

Study Design

The study is divided into three parts:

  1. Part A: This part will determine the best dose of GB1211 to use with atezolizumab[1].
  2. Part B: This part will compare GB1211 plus atezolizumab to a placebo plus atezolizumab. Neither the patients nor the doctors will know who is receiving GB1211 or the placebo (this is called a double-blind study)[1].
  3. Part C: This part will look at the long-term safety and effectiveness of GB1211 with atezolizumab[1].

Potential Benefits and Risks

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

Potential Benefits:

  • Access to a new treatment that may be more effective than current options[1]
  • Close monitoring by healthcare professionals[1]
  • Contributing to the advancement of cancer research[1]

Potential Risks:

  • Unknown side effects from GB1211[1]
  • Possible interactions between GB1211 and atezolizumab[1]
  • The treatment may not be effective for everyone[1]

It’s important to note that this is an ongoing study, and the full benefits and risks of GB1211 are not yet known. Patients considering participating in this or any clinical trial should discuss the potential risks and benefits with their healthcare provider[1].

Aspect Details
Drug Name GB1211 (5-Bromopyridin-3-yl 3-deoxy-1-thio-3-[4-(3,4,5-trifluorophenyl)-1H-1,2,3-triazol-1-yl]-alfa-D-galactopyranoside)
Drug Type Galectin-3 inhibitor
Combination Therapy GB1211 + Atezolizumab
Target Condition Non-Small Cell Lung Cancer (NSCLC) Stage IIIB or IV
Trial Phase Phase I and Phase II (Integrated)
Main Objectives Assess safety, tolerability, and efficacy of GB1211 with atezolizumab
Key Eligibility Criteria Adults with NSCLC, measurable disease, PD-L1 expression ≥50%, no prior systemic chemotherapy or immune checkpoint inhibitors
Primary Endpoints Adverse events, change in tumor size at Week 12
Secondary Endpoints Overall response rate, duration of response, progression-free survival, pharmacokinetics

FAQ

  • What is GB1211 and how does it work? GB1211 is a galectin-3 inhibitor. It works by blocking the action of galectin-3, a protein that may play a role in cancer growth and spread. By combining GB1211 with atezolizumab (an immunotherapy drug), researchers hope to enhance the body's ability to fight cancer cells in patients with Non-Small Cell Lung Cancer.
  • Who is eligible for these clinical trials? Eligible participants are adults (18 years or older) diagnosed with stage IIIB or IV Non-Small Cell Lung Cancer. They must have measurable disease and express certain levels of PD-L1 on their tumor cells. Patients should not have received prior systemic chemotherapy for advanced or metastatic disease or previous immune checkpoint inhibitors.
  • What are the main objectives of the clinical trials? The main objectives are to assess the safety and tolerability of GB1211 in combination with atezolizumab, determine the recommended dose for further study, and evaluate the efficacy of this combination compared to atezolizumab alone in NSCLC patients.
  • How is the effectiveness of the treatment measured? The effectiveness is measured through various methods, including the change in size of target lesions, overall response rate (complete or partial response to treatment), duration of response, and progression-free survival. Researchers also assess the safety profile by monitoring adverse events throughout the study.
  • What are the different parts of the clinical trial? The trial is divided into three parts: Part A focuses on determining the safe and tolerable dose of GB1211 with atezolizumab. Part B is a randomized, double-blind study comparing GB1211 plus atezolizumab to placebo plus atezolizumab. Part C is an extension study to assess long-term safety and efficacy of the combination treatment.

Ongoing Clinical Trials on 5-Bromopyridin-3-Yl 3-Deoxy-1-Thio-3-[4-(3,4,5-Trifluorophenyl)-1H-1,2,3-Triazol-1-Yl]-Alfa-D-Galactopyranoside

  • Study comparing how the body processes GB1211 capsule and tablet forms with and without food in healthy volunteers

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Effectiveness of GB1211 and Atezolizumab for Patients with Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • Galectin-3: A protein that plays a role in various biological processes, including cancer growth and spread. GB1211 is designed to inhibit this protein.
  • Atezolizumab: An immunotherapy drug that helps the immune system fight cancer cells. It's often used in the treatment of various cancers, including NSCLC.
  • PD-L1: A protein found on some cancer cells that helps them evade the immune system. The level of PD-L1 expression can help determine if a patient might benefit from certain immunotherapies.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Overall Response Rate (ORR): The percentage 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 getting worse.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving a placebo or standard treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-gb1211-and-atezolizumab-for-patients-with-non-small-cell-lung-cancer/