Clinical Trial: NCT06188559
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
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Eisai Inc. |
| Information Provided By: | Eisai Inc. |
| Last Update Posted: | 2026-05-22 |
Study Overview
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). 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).
Official 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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: BB-1701
Other Study ID Numbers
- BB-1701-G000-205
- 2023-506866-30
- 2023
Start Date (Actual)
2024-04-10
Primary Completion Date (Actual)
2026-03-18
Study Completion Date (Actual)
2026-03-18
Enrollment (Actual)
56
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Eisai Inc. |
| Information Provided By: | Eisai Inc. |
| Last Update Posted: | 2026-05-22 |
Study Overview
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). 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).
Official 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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: BB-1701
Other Study ID Numbers
- BB-1701-G000-205
- 2023-506866-30
- 2023
Start Date (Actual)
2024-04-10
Primary Completion Date (Actual)
2026-03-18
Study Completion Date (Actual)
2026-03-18
Enrollment (Actual)
56
Study Type
Interventional
Phase
Phase 2