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Humanised Igg1 Kappa Monoclonal Antibody Against Receptor Tyrosine-Protein Kinase Erbb-2 Conjugated To Eribulin

This article discusses the ongoing clinical trials of BB-1701, a new antibody-drug conjugate designed to target HER2-positive and HER2-low metastatic breast cancer. BB-1701 is being studied in a Phase 2 clinical trial to evaluate its safety and effectiveness in patients who have previously received treatment with trastuzumab deruxtecan (T-DXd). The trial aims to determine the optimal dose and assess the drug’s potential in improving outcomes for patients with advanced breast cancer.

Table of Contents

What is BB-1701?

BB-1701 is a new medication being studied for the treatment of certain types of breast cancer[1]. It is classified as an antibody-drug conjugate (ADC), which is a type of targeted therapy that combines the precision of antibodies with the cancer-killing power of chemotherapy drugs[1].

The full name of BB-1701 is quite complex: humanised IgG1 kappa monoclonal antibody against receptor tyrosine-protein kinase ERBB-2 conjugated to eribulin[1]. Let’s break this down:

  • Humanised antibody: This means the antibody is designed to be similar to human antibodies, reducing the chance of the body rejecting it.
  • IgG1 kappa: This refers to the specific type of antibody used.
  • Monoclonal: The antibodies are all identical copies of each other.
  • Against receptor tyrosine-protein kinase ERBB-2: This means the antibody targets a specific protein (ERBB-2, also known as HER2) found on some breast cancer cells.
  • Conjugated to eribulin: The antibody is attached to a chemotherapy drug called eribulin.

How does BB-1701 work?

BB-1701 works by targeting breast cancer cells that have high levels (HER2-positive) or low levels (HER2-low) of a protein called HER2 on their surface[1]. The antibody part of BB-1701 attaches to these HER2 proteins, and then delivers the chemotherapy drug (eribulin) directly to the cancer cells. This targeted approach aims to kill cancer cells while minimizing damage to healthy cells[1].

Who is BB-1701 for?

BB-1701 is being studied for patients with HER2-positive or HER2-low metastatic breast cancer[1]. Metastatic breast cancer means the cancer has spread beyond the breast to other parts of the body. The treatment is specifically for patients who have already received a previous treatment called trastuzumab deruxtecan (T-DXd)[1].

Clinical Trial Details

BB-1701 is currently being studied in a Phase 2 clinical trial[1]. This trial has two parts:

  1. Dose Optimization Part: This part aims to determine the best dose of BB-1701 and assess its safety and tolerability[1].
  2. Dose Expansion Part: This part will assess how well BB-1701 works at fighting cancer (its antitumor activity) at the recommended dose[1].

Potential Benefits

The clinical trial is designed to measure several potential benefits of BB-1701, including[1]:

  • Objective Response Rate (ORR): This measures how many patients see their tumors shrink or disappear.
  • Duration of Response (DOR): This measures how long the cancer remains controlled after treatment.
  • Progression-Free Survival (PFS): This measures how long patients live without their cancer getting worse.
  • Overall Survival (OS): This measures how long patients live after starting treatment.

Safety Considerations

As with any new treatment, safety is a key concern. The trial will closely monitor patients for side effects, including[1]:

  • Changes in blood tests
  • Changes in vital signs and body weight
  • Heart function (through ECGs)
  • Overall health status

Some specific safety concerns being monitored include[1]:

  • Peripheral neuropathy: Numbness or tingling in hands and feet
  • Pneumonitis/Interstitial Lung Disease (ILD): Inflammation in the lungs
  • Heart problems: Including changes in heart function

Eligibility Criteria

To participate in the BB-1701 clinical trial, patients must meet certain criteria. Some key points include[1]:

  • Age 18 or older
  • Diagnosed with HER2-positive or HER2-low metastatic breast cancer
  • Previously treated with trastuzumab deruxtecan (T-DXd)
  • Have received 1-3 prior chemotherapy treatments for metastatic breast cancer
  • Have measurable disease
  • Have a good overall health status (ECOG performance status of 0 or 1)

There are also several factors that would exclude a patient from participating, such as certain brain metastases, active infections, or specific heart conditions[1].

Aspect Details
Drug Name BB-1701 (Humanised IgG1 Kappa Monoclonal Antibody Against Receptor Tyrosine-Protein Kinase ErbB-2 Conjugated to Eribulin)
Trial Phase Phase 2
Target Population HER2-positive or HER2-low metastatic breast cancer patients previously treated with T-DXd
Trial Structure Two parts: Dose Optimization and Dose Expansion
Primary Objectives Determine recommended dose, assess safety and tolerability, evaluate antitumor activity
Key Eligibility Criteria Age ≥18, measurable disease, 1-3 prior chemotherapy regimens, ECOG performance status 0-1
Primary Endpoints Safety assessments, Objective Response Rate (ORR)
Secondary Endpoints Duration of Response, Progression-Free Survival, Overall Survival, Disease Control Rate, Clinical Benefit Rate
Administration Intravenous infusion
Maximum Treatment Period 24 months

FAQ

  • What is BB-1701? BB-1701 is an antibody-drug conjugate (ADC) that targets HER2 (human epidermal growth factor receptor 2) in breast cancer cells. It combines a monoclonal antibody with eribulin, a chemotherapy drug, to deliver targeted treatment to cancer cells.
  • Who is eligible for the BB-1701 clinical trial? The trial is open to patients aged 18 and older with HER2-positive or HER2-low metastatic or unresectable breast cancer who have previously received treatment with trastuzumab deruxtecan (T-DXd). Patients must have measurable disease and adequate organ function.
  • What are the main objectives of the BB-1701 clinical trial? The main objectives are to determine the recommended dose of BB-1701, assess its safety and tolerability, and evaluate its effectiveness in treating HER2-positive and HER2-low metastatic breast cancer.
  • How is the clinical trial structured? The trial is divided into two parts: a Dose Optimization Part to determine the optimal dose and assess safety, and a Dose Expansion Part to evaluate the drug's effectiveness at the recommended dose in selected breast cancer populations.
  • What are the primary endpoints of the study? The primary endpoints include safety assessments (adverse events, lab tests, vital signs) and objective response rate (ORR), which measures the proportion of patients achieving a complete or partial response to the treatment.

Ongoing Clinical Trials on Humanised Igg1 Kappa Monoclonal Antibody Against Receptor Tyrosine-Protein Kinase Erbb-2 Conjugated To Eribulin

  • Study of BB-1701 for Patients with HER2-positive or HER2-low Metastatic Breast Cancer

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

Glossary

  • Antibody-Drug Conjugate (ADC): A type of targeted cancer therapy that combines a monoclonal antibody with a chemotherapy drug to deliver treatment directly to cancer cells.
  • HER2: Human Epidermal growth factor Receptor 2, a protein that promotes the growth of cancer cells. Some breast cancers have higher levels of HER2 and are called HER2-positive.
  • Metastatic Breast Cancer: Breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, or lungs.
  • Unresectable: Referring to a tumor that cannot be completely removed through surgery.
  • Trastuzumab Deruxtecan (T-DXd): An antibody-drug conjugate used to treat certain types of breast cancer that are HER2-positive.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1. A standard way to measure how well a cancer patient responds to treatment.
  • 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 cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial/study-of-bb-1701-for-patients-with-her2-positive-or-her2-low-metastatic-breast-cancer/