Trial Title:
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
NCT ID:
NCT06188559
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Breast carcinoma
Unresectable or metastatic breast cancer
HER2-positive or HER2-low unresectable or metastatic breast cancer
BB-1701
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
For Dose Optimization (Part 1), this study is randomized and for Dose Expansion (Part 2),
there will be no randomization.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BB-1701
Description:
BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).
Arm group label:
Part 1, Dose Optimization, Cohort 1
Arm group label:
Part 1, Dose Optimization, Cohort 2
Arm group label:
Part 1, Dose Optimization, Cohort 3
Arm group label:
Part 2, Dose Expansion
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
- Any medical or other condition which, in the opinion of the investigator would
preclude the participant's participation in the clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF
Address:
City:
San Francisco
Zip:
94143-2208
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612-9416
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology & Hematology
Address:
City:
Fort Wayne
Zip:
48604
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Blood and Cancer
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Cancer and Blood
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University in St. Louis School of Medicine
Address:
City:
Saint Louis
Zip:
63110-1032
Country:
United States
Status:
Recruiting
Facility:
Name:
NHO Revive Research Institute LLC
Address:
City:
Lincoln
Zip:
68506
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Cancer Specialist
Address:
City:
Omaha
Zip:
68130-2042
Country:
United States
Status:
Recruiting
Facility:
Name:
Astera Cancer Care
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Medical Group
Address:
City:
Florham Park
Zip:
07932-1049
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Facility:
Name:
New Mexico Oncology Hematology Consultants
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
Address:
City:
Cleveland
Zip:
44111
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
Address:
City:
Cleveland
Zip:
44124
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195-0001
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Oncology Specialists
Address:
City:
Salem
Zip:
97301
Country:
United States
Status:
Recruiting
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Facility:
Name:
The West Clinic, PLLC dba West Cancer Cente
Address:
City:
Germantown
Zip:
38138-1762
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Medical Specialties
Address:
City:
Puyallup
Zip:
98373-1428
Country:
United States
Status:
Recruiting
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya Shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hyogo Medical University Hospital
Address:
City:
Nishinomiya-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Sagara Hospital, Social Medical Corporation Hakuaikai
Address:
City:
Kagoshima Shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama Shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital (NCCH)
Address:
City:
Chuo-Ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai Shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama Shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Medical University International Medical Center
Address:
City:
Hidaka-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Cancer Center
Address:
City:
Kitaadachi-gun
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address:
City:
Koto Ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
Showa University
Address:
City:
Shinagawa Ku
Country:
Japan
Status:
Recruiting
Start date:
April 10, 2024
Completion date:
October 26, 2026
Lead sponsor:
Agency:
Eisai Inc.
Agency class:
Industry
Collaborator:
Agency:
Bliss Biopharmaceutical (Hangzhou) Co., Ltd
Agency class:
Industry
Source:
Eisai Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06188559
