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).
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)