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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506866-30 | Other Identifier | EU-CT Number |
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| Name | Class |
|---|---|
| Bliss Biopharmaceutical (Hangzhou) Co., Ltd | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Dose Optimization, Cohort 1 | Experimental | HER2-positive or HER2-low, unresectable or metastatic BC. |
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| Part 1, Dose Optimization, Cohort 2 | Experimental | HER2-positive or HER2-low, unresectable or metastatic BC. |
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| Part 1, Dose Optimization, Cohort 3 | Experimental | HER2-positive or HER2-low, unresectable or metastatic BC. |
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| Part 2, Dose Expansion | Experimental | HER2-positive or HER2-low, unresectable or metastatic BC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BB-1701 | Drug | BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, Dose Optimization: Duration of Response (DOR) | DOR defined as the time from the onset date of documented CR or PR for confirmed responses by investigator per RECIST v1.1 to the date of disease progression (PD) or death, whichever occurs first. | From the date of documented CR or PR to the date of PD or death, whichever occurs first (up to 35 months) |
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Inclusion Criteria
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | United States | ||
| UCLA Center for East-West Medicine |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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For Dose Optimization (Part 1), this study is randomized and for Dose Expansion (Part 2), there will be no randomization.
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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) |
| Part 1, Dose Optimization: Progression-free Survival (PFS) | PFS is defined as the time from the date of first dose to the date of the first documentation of PD by investigator per RECIST v1.1 or death, whichever occurs first. | 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) | Overall survival (OS) is defined as the time from the date of first dose to the date of death. OS will be based on Kaplan-Meier estimates. | From the date of first dose to the date of death (up to 35 months) |
| Part 1, Dose Optimization: Disease Control Rate (DCR) | DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) (greater than or equal to [>=] 5 weeks from the first dose) by investigator per RECIST v1.1. | 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) | CBR is defined as the percentage of participants with CR, PR, or durable SD (duration of SD >=23 weeks) by investigator per RECIST v1.1. | From the date of first dose until PD or death, whichever occurs first (up to 35 months) |
| Part 1, Dose Optimization: Time to Response (TTR) | TTR is defined as the time from the date of first dose to the day of the first documented CR or PR for confirmed responses by investigator per RECIST v1.1 | From the date of first dose to the day of the first documented CR or PR (up to 35 months) |
| Part 1, Dose Optimization, Cmax: Maximum Observed Concentration of BB-1701, Total Antibody and Eribulin (Payload) | Baseline up to 35 months |
| Part 1, Dose Optimization, Tmax: Time to Reach Maximum Observed Concentration (Cmax) of BB-1701, Total Antibody and Eribulin (Payload) | Baseline up to 35 months |
| Part 1, Dose Optimization, AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration of BB-1701, Total Antibody and Eribulin (Payload) | Baseline up to 35 months |
| Part 1, Dose Optimization, AUC(0-inf): Area Under the Concentration-time Curve From Zero Time to Infinity of BB-1701, Total Antibody and Eribulin (Payload) | Baseline up to 35 months |
| Part 1, Dose Optimization, t1/2: Terminal Phase Elimination Half-life of BB-1701 | Baseline up to 35 months |
| Part 1, Dose Optimization, CL: Total Body Clearance of BB-1701 | Baseline up to 35 months |
| Part 1, Dose Optimization, Vss: Volume of Distribution at Steady State for BB-1701 | Baseline up to 35 months |
| Part 1, Dose Optimization, Ctrough: Trough Concentration of BB-1701 | Baseline up to 35 months |
| Part 1, Dose Optimization: Statistical Correlation Between Serum Concentrations of BB-1701 with ORR and AEs | Baseline up to 35 months |
| Part 2, Dose Expansion: Duration of Response (DOR) Based on BICR Assessment by RECIST v1.1 | DOR is defined as the time from the onset date of documented CR or PR for confirmed responses based on BICR by RECIST v1.1 to the date of PD or death, whichever occurs first. | From the date of documented CR or PR to the date of PD or death, whichever occurs first (up to 35 months) |
| Part 2, Dose Expansion: Disease Control Rate (DCR) Based on BICR Assessment per RECIST v1.1 | DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) (>=5 weeks from the first dose) based on BICR per RECIST v1.1. | From the date of first dose until first documentation of CR or PR or SD (up to 35 months) |
| Part 2, Dose Expansion: Time to Response (TTR) Based on BICR Assessment per RECIST v1.1 | TTR is defined as the time from the date of first dose to the day of the first documented CR or PR for confirmed responses based on BICR per RECIST v1.1 | From the date of first dose to the day of the first documented CR or PR (up to 35 months) |
| Part 2, Dose Expansion: Clinical Benefit Rate (CBR) Based on BICR Assessment per RECIST v1.1 | CBR is defined as the percentage of participants with CR, PR, or durable SD (duration of SD >=23 weeks) based on BICR per RECIST v1.1. | From the date of first dose until PD or death, whichever occurs first (up to 35 months) |
| Part 2, Dose Expansion: Progression-free Survival (PFS) Based on BICR Assessment per RECIST v1.1 | PFS is defined as the time from the date of first dose to the date of the first documentation of PD based on BICR per RECIST v1.1 or death, whichever occurs first. | 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 2, Dose Expansion: Overall Survival (OS) | Overall survival (OS) is defined as the time from the date of first dose to the date of death. OS will be based on Kaplan-Meier estimates. | From the date of first dose to the date of death (up to 35 months) |
| Part 2, Dose Expansion: Number of Participants With 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, 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 2, Dose Expansion: Number of Participants With Clinically Significant Laboratory Values | Clinical laboratory parameters includes hematology, chemistry, and urinalysis. | Baseline up to 35 months |
| Part 2, Dose Expansion: Number of Participants With Clinically Significant Vital Sign Values | Vital sign parameters includes systolic and diastolic BP, pulse, respiratory rate, body temperature. | Baseline up to 35 months |
| Part 2, Dose Expansion: 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 2, Dose Expansion: 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 |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCSF | San Francisco | California | 94143-2208 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| AdventHealth Cancer Institute - Orlando | Orlando | Florida | 32804 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612-9416 | United States |
| Fort Wayne Medical Oncology & Hematology | Fort Wayne | Indiana | 48604 | United States |
| Community Cancer Center South | Indianapolis | Indiana | 46227 | United States |
| Mission Blood and Cancer | Des Moines | Iowa | 50309 | United States |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109-5000 | United States |
| Washington University in St. Louis School of Medicine | St Louis | Missouri | 63110-1032 | United States |
| NHO Revive Research Institute LLC | Lincoln | Nebraska | 68506 | United States |
| Nebraska Cancer Specialist | Omaha | Nebraska | 68130-2042 | United States |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | United States |
| Summit Medical Group | Florham Park | New Jersey | 07932-1049 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center) | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center | Cleveland | Ohio | 44124 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | United States |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | United States |
| UPMC CancerCenter at Magee - Womens Hospital | Pittsburgh | Pennsylvania | 15213-3108 | United States |
| St. Francis Cancer Center | Greenville | South Carolina | 29607-5253 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| The West Clinic, PLLC dba West Cancer Cente | Germantown | Tennessee | 38138-1762 | United States |
| Northwest Medical Specialties | Puyallup | Washington | 98373-1428 | United States |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | France |
| Institut Régional du Cancer de Montpellier | Montpellier | France |
| Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO) | Plérin | France |
| Institut de Cancerologie de Ouest (ICO) - Saint-Herblain | Saint-Herblain | France |
| Nagoya University Hospital | Nagoya | Aichi-ken | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Hiroshima | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | Japan |
| Hyogo Medical University Hospital | Nishinomiya-shi | Hyōgo | Japan |
| Sagara Hospital, Social Medical Corporation Hakuaikai | Kagoshima | Kagoshima-ken | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Japan |
| Kyoto University Hospital | Sakyo-ku | Kyoto | Japan |
| Tohoku University Hospital | Sendai | Miyagi | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | Japan |
| Saitama Medical University International Medical Center | Hidaka-shi | Saitama | Japan |
| Saitama Cancer Center | Kitaadachi-gun | Saitama | Japan |
| National Cancer Center Hospital (NCCH) | Chuo-Ku | Tokyo | Japan |
| St. Luke's International Hospital | Chuou-ku | Tokyo | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto Ku | Tokyo | Japan |
| Showa Medical University | Shinagawa Ku | Tokyo | Japan |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| HM Universitario Sanchinarro | Madrid | Spain |
| Hospital Beata María Ana | Madrid | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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