In short
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.
At a glance
- 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
What is BB-1701?
BB-1701 is a new medication being studied for the treatment of certain types of breast cancer. 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.
The full name of BB-1701 is quite complex: humanised IgG1 kappa monoclonal antibody against receptor tyrosine-protein kinase ERBB-2 conjugated to eribulin. 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. 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.
Who is BB-1701 for?
BB-1701 is being studied for patients with HER2-positive or HER2-low metastatic breast cancer. 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).
Clinical Trial Details
BB-1701 is currently being studied in a Phase 2 clinical trial. This trial has two parts:
- Dose Optimization Part: This part aims to determine the best dose of BB-1701 and assess its safety and tolerability.
- Dose Expansion Part: This part will assess how well BB-1701 works at fighting cancer (its antitumor activity) at the recommended dose.
Potential Benefits
The clinical trial is designed to measure several potential benefits of BB-1701, including:
- 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:
- 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:
- 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:
- 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.