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

NCT06188559 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: BB-1701-G000-2052023-506866-30
• Study Type: interventional
• Target: 135
• Locations: 4 countries
• Sites: 49

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).

Conditions

Breast Cancer

Keywords

Breast cancer; Breast carcinoma; Unresectable or metastatic breast cancer; HER2-positive or HER2-low unresectable or metastatic breast cancer; BB-1701

Outcome Measures

Primary Outcomes (7)

• Part 1, Dose Optimization: Number of Participants With Adverse Events (AEs)

  An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product; Any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (example, electrocardiogram \[ECG\] or x-ray) that results in symptoms, a change in treatment, or discontinuation of study drug; Recurrence of an intermittent medical condition (example, headache) not present pretreatment (baseline); An abnormal laboratory test result should be considered an AE if the identified laboratory abnormality leads to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not. An AE does not necessarily have a causal relationship with the medicinal product.

  Baseline up to 35 months

• Part 1, Dose Optimization: Number of Participants With Clinically Significant Laboratory Values

  Clinical laboratory parameters includes hematology, chemistry, and urinalysis.

  Baseline up to 35 months

• Part 1, Dose Optimization: Number of Participants With Clinically Significant Vital Sign Values

  Vital sign parameters includes systolic and diastolic blood pressure (BP), pulse, respiratory rate, body temperature.

  Baseline up to 35 months

• Part 1, Dose Optimization: Number of Participants With Clinically Significant 12-lead ECGs Values

  Number of participants with clinically significant 12-lead ECGs values will be reported.

  Baseline up to 35 months

• Part 1, Dose Optimization: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

  Number of participants with ECOG PS will be reported.

  Baseline up to 35 months

• Part 1, Dose Optimization: Objective Response Rate (ORR)

  ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or confirmed partial response (PR) by investigator assessment per Response Evaluation Criteria for Solid Tumours (RECIST) version (v) 1.1.

  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

  ORR is defined as the percentage of participants achieving a confirmed CR or confirmed PR based on BICR assessment per RECIST v1.1.

  From date of first dose of study drug until first documentation of CR or PR (up to 35 months)

Secondary Outcomes (26)

• Part 1, Dose Optimization: Duration of Response (DOR)

  From the date of documented CR or PR to the date of PD or death, whichever occurs first (up to 35 months)

• Part 1, Dose Optimization: Progression-free Survival (PFS)

  From the date of first dose to the date of the first documentation of PD or death, whichever occurs first (up to 35 months)

• Part 1, Dose Optimization: Overall Survival (OS)

  From the date of first dose to the date of death (up to 35 months)

• Part 1, Dose Optimization: Disease Control Rate (DCR)

  From the date of first dose until PD or death, whichever occurs first (up to 35 months)

• Part 1, Dose Optimization: Clinical Benefit Rate (CBR)

  From the date of first dose until PD or death, whichever occurs first (up to 35 months)

Study Arms (4)

Part 1, Dose Optimization, Cohort 1

EXPERIMENTAL

HER2-positive or HER2-low, unresectable or metastatic BC.

Drug: BB-1701

Part 1, Dose Optimization, Cohort 2

EXPERIMENTAL

HER2-positive or HER2-low, unresectable or metastatic BC.

Drug: BB-1701

Part 1, Dose Optimization, Cohort 3

EXPERIMENTAL

HER2-positive or HER2-low, unresectable or metastatic BC.

Drug: BB-1701

Part 2, Dose Expansion

EXPERIMENTAL

HER2-positive or HER2-low, unresectable or metastatic BC.

Drug: BB-1701

Interventions

BB-1701 DRUG

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

Part 1, Dose Optimization, Cohort 1; Part 1, Dose Optimization, Cohort 2; Part 1, Dose Optimization, Cohort 3; Part 2, Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged \>=18 years at the time of informed consent.
• Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive (defined as an immunohistochemistry \[IHC\] status of 3+, or a positive in situ hybridization \[ISH\] test \[fluorescence, chromogenic, or silver-enhanced ISH\] if IHC status is 2+) or HER2-low (defined as an IHC status of 1+, or 2+ and negative ISH) per the American Society of Clinical Oncology/College of American Pathology guidelines as documented prior to trastuzumab deruxtecan (T-DXd) treatment.
• Must have previously received T-DXd.
• Sufficient tumor tissue is required for HER2 status testing at a central laboratory.
• Measurable disease per RECIST 1.1 as assessed by the investigator. Participants with bone only disease may be eligible if there is a measurable soft tissue component associated with the bone lesion.
• Must have previously received at least 1 but no more than 3 prior chemotherapy-based regimes in the unresectable or metastatic setting. If recurrence occurred during or within 6 months of (neo) adjuvant chemotherapy, this would count as 1 line of chemotherapy.
• If HR-positive HER2-low BC, must have previously received endocrine therapy and is not expected to further benefit from it.
• ECOG PS 0 or 1.
• Life expectancy of at least 3 months.
• Adequate organ function and laboratory parameters.

You may not qualify if:

• Presence of brain or subdural metastases, unless participant has completed local therapy and has discontinued the use of corticosteroids for this indication for at least 2 weeks prior to starting treatment in this study.
• Diagnosed with meningeal carcinomatosis.
• Received anticancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, etc) or an investigational drug or device within the past 28 days or 5 half-lives, whichever is shorter.
• Prior treatment with eribulin.
• Any prior allergic reactions of Grade \>=3 to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
• Residual toxic effects of prior therapies or surgical procedures that is Grade \>=2 (except alopecia or anemia).
• Grade \>=2 peripheral neuropathy or history of Grade \>=3 peripheral neuropathy or discontinued any prior treatment due to peripheral neuropathy.
• Active pneumonitis/interstitial lung disease (ILD) or any clinically significant lung disease (example, chronic obstructive pulmonary disease), history of Grade \>=2 pneumonitis/ILD, or received radiotherapy to lung fields within 12 months of Cycle 1 Day 1 of study treatment.
• Congestive heart failure greater than (\>) New York Heart Association Class II or left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) measured by multigated acquisition scan (MUGA) or echocardiogram.
• Has a corrected QT interval prolongation per Fridericia formula (QTcF) \>470 millisecond (ms) (for both males and females) based on screening triplicate 12-lead ECG.
• Concomitant active infection requiring systemic treatment, except:
• If known to be human immunodeficiency virus (HIV)-positive, must be on anti-HIV therapy for at least 4 weeks and have a clusters of differentiation 4+ T-cell (CD4+) count \>=350 cells per microliter (cells/mcL) and an HIV viral load \<400 copies per milliliter (copies/mL).
• If meets the criteria for anti-hepatitis B virus (HBV) therapy, must agree to take anti-HBV therapy, if known to be HBV-positive as defined by positive hepatitis B surface antigen or hepatitis B core antibody. HBV viral load must be undetectable.
• If known to be hepatitis C virus (HCV)-positive must have completed curative therapy for HCV. HCV viral load must be undetectable.
• Known history of active bacillus tuberculosis (TB).

Sponsors & Collaborators

• Eisai Inc.: lead
• Bliss Biopharmaceutical (Hangzhou) Co., Ltd: collaborator

Study Sites (49)

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

Location

UCLA Center for East-West Medicine

Los Angeles, California, 90095, United States

Location

UCSF

San Francisco, California, 94143-2208, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

AdventHealth Cancer Institute - Orlando

Orlando, Florida, 32804, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612-9416, United States

Location

Fort Wayne Medical Oncology & Hematology

Fort Wayne, Indiana, 48604, United States

Location

Community Cancer Center South

Indianapolis, Indiana, 46227, United States

Location

Mission Blood and Cancer

Des Moines, Iowa, 50309, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109-5000, United States

Location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110-1032, United States

Location

NHO Revive Research Institute LLC

Lincoln, Nebraska, 68506, United States

Location

Nebraska Cancer Specialist

Omaha, Nebraska, 68130-2042, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932-1049, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center

Cleveland, Ohio, 44124, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195-0001, United States

Location

Oregon Oncology Specialists

Salem, Oregon, 97301, United States

Location

UPMC CancerCenter at Magee - Womens Hospital

Pittsburgh, Pennsylvania, 15213-3108, United States

Location

St. Francis Cancer Center

Greenville, South Carolina, 29607-5253, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

The West Clinic, PLLC dba West Cancer Cente

Germantown, Tennessee, 38138-1762, United States

Location

Northwest Medical Specialties

Puyallup, Washington, 98373-1428, United States

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, France

Location

Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)

Plérin, France

Location

Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

Saint-Herblain, France

Location

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Hiroshima, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Hyogo Medical University Hospital

Nishinomiya-shi, Hyōgo, Japan

Location

Sagara Hospital, Social Medical Corporation Hakuaikai

Kagoshima, Kagoshima-ken, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Location

Kyoto University Hospital

Sakyo-ku, Kyoto, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Location

Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

Location

National Cancer Center Hospital (NCCH)

Chuo-Ku, Tokyo, Japan

Location

St. Luke's International Hospital

Chuou-ku, Tokyo, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto Ku, Tokyo, Japan

Location

Showa Medical University

Shinagawa Ku, Tokyo, Japan

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

HM Universitario Sanchinarro

Madrid, Spain

Location

Hospital Beata María Ana

Madrid, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For Dose Optimization (Part 1), this study is randomized and for Dose Expansion (Part 2), there will be no randomization.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 3, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (15); ES (3); US (27); FR (4)