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).
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Part 1, Dose Optimization: Number of Participants With Adverse Events (AEs)
Timeframe: Baseline up to 35 months
Part 1, Dose Optimization: Number of Participants With Clinically Significant Laboratory Values
Timeframe: Baseline up to 35 months
Part 1, Dose Optimization: Number of Participants With Clinically Significant Vital Sign Values
Timeframe: Baseline up to 35 months
Part 1, Dose Optimization: Number of Participants With Clinically Significant 12-lead ECGs Values
Timeframe: Baseline up to 35 months
Part 1, Dose Optimization: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Timeframe: Baseline up to 35 months
Part 1, Dose Optimization: Objective Response Rate (ORR)
Timeframe: From date of first dose of study drug until first documentation of CR or PR (up to 35 months)
Part 2, Dose Expansion: Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment per RECIST v1.1
Timeframe: From date of first dose of study drug until first documentation of CR or PR (up to 35 months)