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

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as HER2-positive or HER2-low metastatic breast cancer. This type of cancer is characterized by the presence of a protein called HER2 on the surface of cancer cells, which can promote the growth of cancer. The study will use a treatment called BB-1701, which is a special kind of medication known as an antibody-drug conjugate. This means it combines an antibody, which can specifically target cancer cells, with a drug that can kill these cells. The antibody in BB-1701 is designed to target the HER2 protein, and it is linked to a drug called eribulin, which helps to stop cancer cells from growing and dividing.

The purpose of the study is to find the best dose of BB-1701 and to see how safe and effective it is for people who have already received treatment for their cancer. The study will be conducted in two parts. In the first part, different doses of BB-1701 will be tested to find the most suitable one. In the second part, the chosen dose will be given to more participants to further evaluate its effects. Participants will receive the treatment through an infusion, which means the medication will be given directly into a vein.

Throughout the study, the safety of BB-1701 will be closely monitored by checking for any side effects and conducting regular health assessments. The effectiveness of the treatment will be evaluated by observing how the cancer responds to the medication. This includes looking at whether the cancer shrinks or stops growing. The study aims to provide valuable information about the potential benefits of BB-1701 for treating HER2-positive or HER2-low metastatic breast cancer.

1 joining the study

Upon joining the study, the patient will provide written consent to participate. This step ensures understanding and agreement to follow the study protocol.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of HER2-positive or HER2-low metastatic breast cancer and ensuring adequate organ function.

3 treatment phase 1: dose optimization

The patient will receive the medication BB-1701, which is a solution for infusion administered intravenously. The goal is to determine the optimal dose for further study.

During this phase, the patient’s response to the medication will be closely monitored, including any side effects and changes in health status.

4 treatment phase 2: dose expansion

Once the optimal dose is determined, the patient will continue to receive BB-1701 at this dose. The focus will be on evaluating the medication’s effectiveness in treating the cancer.

Regular assessments will be conducted to monitor the patient’s response to treatment and any potential side effects.

5 ongoing monitoring

Throughout the study, the patient will undergo regular health checks, including laboratory tests, vital signs monitoring, and ECGs to ensure safety and track progress.

The patient’s overall health and any changes in the cancer will be documented to assess the treatment’s impact.

6 completion of study

Upon completion of the study, the patient will have a final assessment to evaluate the overall outcomes of the treatment.

The study is expected to conclude by November 2028, with ongoing follow-up as needed to ensure the patient’s well-being.

Who Can Join the Study?

  • The patient must be willing and able to follow all parts of the study plan and must provide written permission to participate before any study-specific checks are done.
  • The patient should have a life expectancy of at least 3 months.
  • The patient must have proper functioning of organs and acceptable lab test results.
  • The patient can be male or female and must be 18 years or older at the time of giving consent.
  • The patient must have breast cancer that has spread to other parts of the body or cannot be removed by surgery. The cancer must be confirmed to be either HER2-positive or HER2-low. HER2 is a protein that can affect the growth of cancer cells.
  • The patient must have previously received a treatment called T-DXd.
  • There must be enough tumor tissue available for testing the HER2 status in a central lab.
  • The patient must have a measurable disease, which means the cancer can be measured in size. If the cancer is only in the bones, it may still be eligible if there is a measurable soft tissue part.
  • The patient must have received at least 1 but no more than 3 previous chemotherapy treatments for cancer that cannot be removed or has spread. If the cancer came back during or within 6 months after chemotherapy given before or after surgery, it counts as one treatment.
  • If the patient has HR-positive HER2-low breast cancer, they must have received hormone therapy before and are not expected to benefit from it anymore. HR-positive means the cancer grows in response to hormones.
  • The patient must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.

Who Cannot Join the Study?

  • Patients who have a different type of cancer that is not HER2 positive or HER2-low metastatic breast cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the selected population group for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other medical conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Hospital Universitario Hm Sanchinarro Madrid Spain
Comite Entreprise Paul Papin Angers France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
MD Anderson Cancer Center Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
Hopital Prive Des Cotes D’armor Plerin France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Iaxhhovt Rtbooomf Dv Cuwimr Dm Mzticoujcsa Montpellier France
Ukchnaofwomlgylgnlhci Daeqjknkzkz Awr Duesseldorf Germany
Bhypodbs Usyhtrtaaq Hpniizna Ctmklw Besançon France
Fuckmoyxx Pazr Lg Isurexukfptsh Bhiqiilfi Dyt Hpfnbmfq Uwqdilspedcsy Ll Pfv Madrid Spain
Kcerckdd Eeacjnvxemejxhutyirugjhd Hxhiqanmsgxstnspl Essen Germany
Hdbhyxwr Vfji dbindpkt Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
04.09.2024
Germany Germany
Not recruiting
04.09.2024
Spain Spain
Not recruiting
04.09.2024

Trial locations

Investigated drugs:

BB-1701 is an experimental medication being studied for its potential to treat breast cancer. It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody with a drug to target cancer cells more precisely. The antibody part of BB-1701 is designed to attach to a specific protein called HER2, which is found on some breast cancer cells. Once attached, the drug part of BB-1701 is delivered directly to the cancer cells, where it can help to kill them. This study is exploring the best dose of BB-1701 and how well it works in patients with HER2-positive or HER2-low breast cancer that cannot be removed by surgery or has spread to other parts of the body.

Investigated diseases:

HER2-positive or HER2-low metastatic breast cancer – This type of breast cancer is characterized by the overexpression or low expression of the HER2 protein on the surface of cancer cells. HER2-positive breast cancer tends to grow and spread more aggressively than other types of breast cancer. Metastatic breast cancer means that the cancer has spread beyond the breast to other parts of the body. The progression of this disease can vary, with some patients experiencing rapid advancement while others may have a slower progression. The presence of HER2 can influence the behavior of the cancer and its response to certain treatments. Understanding the HER2 status is crucial for determining the appropriate management strategy for the disease.

Trial ID:
2023-506866-30-00
Protocol code:
BB-1701-G000-205
NCT ID:
NCT06188559
Trial Phase:
Therapeutic exploratory (Phase II)

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