Eisai Clinical Trials

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

BB-1701-G000-205

Study Overview

BB-1701
N/A
NCT06188559, 2023-506866-30
Apr 2024 -
Breast Cancer
1. Part 1, Dose Optimization: Number of Participants With Adverse Events (AEs) [Time Frame: Baseline up to 35 months]

2. Part 1, Dose Optimization: Number of Participants With Clinically Significant Laboratory Values [Time Frame: Baseline up to 35 months]

3. Part 1, Dose Optimization: Number of Participants With Clinically Significant Vital Sign Values [Time Frame: Baseline up to 35 months]

4. Part 1, Dose Optimization: Number of Participants With Clinically Significant 12-lead ECGs Values [Time Frame: Baseline up to 35 months]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Active, not recruiting

  • Phase 2

  • France, Germany, Japan, Spain, United States See more

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR