Clinical Trial 23063

• Overview

  Study Title:

  An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an anti-human epidermal growth factor receptor 2 (anti-HER2) antibody-drug conjugate (ADC), in Previously Treated Subjects with HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer

  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). The primary purpose of Dose Expansion (Part 2) is to assess the antitumor activity of BB-1701 at RD in the selected population(s) of breast cancer (BC).

  Objective:

  Primary: * To determine the recommended dose (RD) of BB-1701 for Dose Expansion * To assess the safety and tolerability of BB-1701 in each dose cohort Secondary: * To assess additional efficacy measures of BB-1701 in each dose cohort * To characterize the pharmacokinetics (PK) of BB-1701 and the relationship between BB-1701 exposure and selected efficacy and safety measures

• Treatments

  Therapies:

  Antibody-Drug Conjugate

  Medications:

  BB-1701 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Male or female, aged 18 years or older 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0 or 1.
  • Life expectancy of at least 3 months.
  • Adequate organ function and laboratory parameters.

• Exclusion Criteria

  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 (> 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.
  • 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.

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