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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06188559

Public ClinicalTrials.gov record NCT06188559. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:51 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT06188559
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Eisai Inc.
Industry
Enrollment
56 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 10, 2024 (Actual)
Primary completion
Mar 18, 2026 (Actual)
Completion
Mar 18, 2026 (Actual)
Last update posted
May 22, 2026

2024 – 2026

United States locations

U.S. sites
27
U.S. states
18
U.S. cities
25
Facility City State ZIP Site status
Cancer and Blood Specialty Clinic Los Alamitos California 90720 —
UCLA Center for East-West Medicine Los Angeles California 90095 —
UCSF San Francisco California 94143-2208 —
Yale New Haven Hospital New Haven Connecticut 06510 —
AdventHealth Cancer Institute - Orlando Orlando Florida 32804 —
Moffitt Cancer Center Tampa Florida 33612-9416 —
Fort Wayne Medical Oncology & Hematology Fort Wayne Indiana 48604 —
Community Cancer Center South Indianapolis Indiana 46227 —
Mission Blood and Cancer Des Moines Iowa 50309 —
University of Michigan Hospital Ann Arbor Michigan 48109-5000 —
Washington University in St. Louis School of Medicine St Louis Missouri 63110-1032 —
NHO Revive Research Institute LLC Lincoln Nebraska 68506 —
Nebraska Cancer Specialist Omaha Nebraska 68130-2042 —
Astera Cancer Care East Brunswick New Jersey 08816 —
Summit Medical Group Florham Park New Jersey 07932-1049 —
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903 —
New Mexico Oncology Hematology Consultants Albuquerque New Mexico 87109 —
Memorial Sloan-Kettering Cancer Center New York New York 10065 —
Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center) Cleveland Ohio 44111 —
Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center Cleveland Ohio 44124 —
Cleveland Clinic Cleveland Ohio 44195-0001 —
Oregon Oncology Specialists Salem Oregon 97301 —
UPMC CancerCenter at Magee - Womens Hospital Pittsburgh Pennsylvania 15213-3108 —
St. Francis Cancer Center Greenville South Carolina 29607-5253 —
Avera Cancer Institute Sioux Falls South Dakota 57105 —
The West Clinic, PLLC dba West Cancer Cente Germantown Tennessee 38138-1762 —
Northwest Medical Specialties Puyallup Washington 98373-1428 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06188559, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 22, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06188559 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →