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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

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

Protocol Number: 042314
Phase: Phase II
Applicable Disease Sites: Breast
Drugs Involved: BB-1701
Principal Investigator: Mridula A George
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
    • Jersey City Medical Center, Jersey City
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.