Phase 2 Study of BB-1701 in HER2 positive or HER2-low metastatic breast cancer

Phase 1

Conditions: HER2 positive or HER2-low metastatic breast cancer
MedDRA version: 20.1Level: PTClassification code: 10055113Term: Breast cancer metastatic Class: 100000004864
MedDRA version: 23.0Level: PTClassification code: 10065430Term: HER2 positive breast cancer Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code: 10027475Term: Metastatic breast cancer Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-506866-30-00

Lead Sponsor: Eisai Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

Subject must be willing and able to comply with all aspects of the protocol and as such provide written informed consent prior to any study-specific screening procedures., Life expectancy of at least 3 months., Adequate organ function and laboratory parameters., Male or female, aged =18 years at the time of informed consent., Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive (defined as an immunohistochemistry [IHC] status of 3+, or a positive in situ hybridization [ISH] test [fluorescence, chromogenic, or silver-enhanced ISH] if IHC status is 2+) or HER2- low (defined as an IHC status of 1+, or 2+ and negative ISH) per the American Society of Clinical Oncology/College of American Pathology guidelines as documented prior to T-DXd treatment., Must have previously received T-DXd., Sufficient tumor tissue is required for HER2 status testing at a central laboratory., Measurable disease meeting the following criteria as assessed by the investigator:according to RECIST 1.1. NOTE: Subjects with bone only disease may be eligible if there is a measurable soft tissue component associated with the bone lesion., Must have previously received at least 1 but no more than 3 prior chemotherapy-based regimens in the unresectable or metastatic setting. If recurrence occurred during or within 6 months of (neo)adjuvant chemotherapy, this would count as 1 line of chemotherapy., If HR-positive HER2-low BC, must have previously received endocrine therapy and is not expected to further benefit from it., Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Exclusion Criteria

Presence of brain or subdural metastases, unless subject has completed local therapy and has discontinued the use of corticosteroids for this indication for at least 2 weeks prior to starting treatment in this study., Concomitant active infection requiring systemic treatment, except: - If known to be human immunodeficiency virus (HIV)-positive, must be on anti-HIV therapy for at least 4 weeks and have a CD4+ T-cell (CD4+) count =350 cells/µL and an HIV viral load less than 400 copies/mL - If meets the criteria for anti-hepatitis B virus (HBV) therapy, must agree to take anti-HBV therapy, if known to be HBV-positive as defined by positive hepatitis B surface antigen or hepatitis B core antibody. HBV viral load must be undetectable. - If known to be hepatitis C virus (HCV)-positive must have completed curative therapy for HCV. HCV viral load must be undetectable., Known history of active bacillus tuberculosis (TB)., Any medical or other condition which, in the opinion of the investigator, would preclude the subject’s participation in the clinical study., Diagnosed with meningeal carcinomatosis., Received anticancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, etc) or an investigational drug or device within the past 28 days or 5 half-lives, whichever is shorter., Prior treatment with eribulin., Any prior allergic reactions of Grade =3 to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid)., Residual toxic effects of prior therapies or surgical procedures that is Grade =2 (except alopecia or anemia)., Grade =2 peripheral neuropathy or history of Grade =3 peripheral neuropathy or discontinued any prior treatment due to peripheral neuropathy., Active pneumonitis/interstitial lung disease (ILD) or any clinically significant lung disease (eg, chronic obstructive pulmonary disease), history of Grade =2 pneumonitis/ILD, or received radiotherapy to lung fields within 12 months of Cycle 1 Day 1 of study treatment., Any of the following cardiac conditions: - Congestive heart failure greater than New York Heart Association Class II or left ventricular ejection fraction (LVEF) <50% measured by multigated acquisition (MUGA) scan or echocardiogram. - Has a corrected QT interval prolongation per Fridericia formula (QTcF) >470 ms (for both males and females) based on screening triplicate 12-lead ECG.