Status:
ACTIVE_NOT_RECRUITING
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Bliss Biopharmaceutical (Hangzhou) Co., Ltd
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 trastuzumab deruxtecan (T-DXd) treatment.
- Must have previously received T-DXd.
- Sufficient tumor tissue is required for HER2 status testing at a central laboratory.
- Measurable disease per RECIST 1.1 as assessed by the investigator. Participants 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 regimes 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.
- ECOG PS 0 or 1.
- Life expectancy of at least 3 months.
- Adequate organ function and laboratory parameters.
- Exclusion Criteria
- Presence of brain or subdural metastases, unless participant 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.
- 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 (example, 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.
- Congestive heart failure greater than (\>) New York Heart Association Class II or left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) measured by multigated acquisition scan (MUGA) or echocardiogram.
- Has a corrected QT interval prolongation per Fridericia formula (QTcF) \>470 millisecond (ms) (for both males and females) based on screening triplicate 12-lead ECG.
- 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 clusters of differentiation 4+ T-cell (CD4+) count \>=350 cells per microliter (cells/mcL) and an HIV viral load \<400 copies per milliliter (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 participant's participation in the clinical study.
Exclusion
Key Trial Info
Start Date :
April 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06188559
Start Date
April 10 2024
End Date
March 31 2026
Last Update
April 25 2025
Active Locations (49)
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1
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
2
UCLA Center for East-West Medicine
Los Angeles, California, United States, 90095
3
UCSF
San Francisco, California, United States, 94143-2208
4
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510