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
- Registration Number
- NCT06188559
- Lead Sponsor
- Eisai Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 135
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1, Dose Optimization, Cohort 3 BB-1701 HER2-positive or HER2-low, unresectable or metastatic BC. Part 2, Dose Expansion BB-1701 HER2-positive or HER2-low, unresectable or metastatic BC. Part 1, Dose Optimization, Cohort 2 BB-1701 HER2-positive or HER2-low, unresectable or metastatic BC. Part 1, Dose Optimization, Cohort 1 BB-1701 HER2-positive or HER2-low, unresectable or metastatic BC.
- Primary Outcome Measures
Name Time Method Part 1, Dose Optimization: Number of Participants With Clinically Significant 12-lead ECGs Values Baseline up to 35 months Number of participants with clinically significant 12-lead ECGs values will be reported.
Part 1, Dose Optimization: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Baseline up to 35 months Number of participants with ECOG PS will be reported.
Part 1, Dose Optimization: Number of Participants With Adverse Events (AEs) Baseline up to 35 months 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.
Part 1, Dose Optimization: Number of Participants With Clinically Significant Laboratory Values Baseline up to 35 months Clinical laboratory parameters includes hematology, chemistry, and urinalysis.
Part 1, Dose Optimization: Number of Participants With Clinically Significant Vital Sign Values Baseline up to 35 months Vital sign parameters includes systolic and diastolic blood pressure (BP), pulse, respiratory rate, body temperature.
Part 1, Dose Optimization: Objective Response Rate (ORR) From date of first dose of study drug until first documentation of CR or PR (up to 35 months) 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.
Part 2, Dose Expansion: Objective Response Rate (ORR) Based on Blinded Independent Central Review (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) ORR is defined as the percentage of participants achieving a confirmed CR or confirmed PR based on BICR assessment per RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Part 1, Dose Optimization: Overall Survival (OS) From the date of first dose to the date of death (up to 35 months) 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.
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) 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.
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) 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.
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) 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.
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-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 2, Dose Expansion: Number of Participants With Clinically Significant Laboratory Values Baseline up to 35 months Clinical laboratory parameters includes hematology, chemistry, and urinalysis.
Part 1, Dose Optimization: Time to Response (TTR) From the date of first dose to the day of the first documented CR or PR (up to 35 months) 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
Part 1, Dose Optimization, CL: Total Body Clearance 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 From the date of documented CR or PR to the date of PD or death, whichever occurs first (up to 35 months) 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.
Part 2, Dose Expansion: Number of Participants With Clinically Significant Vital Sign Values Baseline up to 35 months Vital sign parameters includes systolic and diastolic BP, pulse, respiratory rate, body temperature.
Part 2, Dose Expansion: Number of Participants With Clinically Significant 12-lead ECGs Values Baseline up to 35 months Number of participants with clinically significant 12-lead ECGs values will be reported.
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) 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.
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 2, Dose Expansion: Clinical Benefit Rate (CBR) Based on BICR Assessment per RECIST v1.1 From the date of first dose until PD or death, whichever occurs first (up to 35 months) 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.
Part 2, Dose Expansion: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Baseline up to 35 months Number of participants with ECOG PS will be reported.
Part 1, Dose Optimization, t1/2: Terminal Phase Elimination Half-life 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 2, Dose Expansion: Disease Control Rate (DCR) Based on BICR Assessment per RECIST v1.1 From the date of first dose until first documentation of CR or PR or SD (up to 35 months) 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.
Part 2, Dose Expansion: Overall Survival (OS) From the date of first dose to the date of death (up to 35 months) 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.
Part 2, Dose Expansion: Number of Participants With AEs Baseline up to 35 months 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.
Part 2, Dose Expansion: Time to Response (TTR) Based on BICR Assessment per RECIST v1.1 From the date of first dose to the day of the first documented CR or PR (up to 35 months) 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
Part 2, Dose Expansion: Progression-free Survival (PFS) Based on BICR Assessment per RECIST v1.1 From the date of first dose to the date of the first documentation of PD or death, whichever occurs first (up to 35 months) 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.
Trial Locations
- Locations (49)
UCLA Center for East-West Medicine
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
AdventHealth Cancer Institute - Orlando
🇺🇸Orlando, Florida, United States
Community Cancer Center South
🇺🇸Indianapolis, Indiana, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
UPMC CancerCenter at Magee - Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St. Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
CHU Besançon - Hôpital Jean Minjoz
🇫🇷Besancon, France
Institut Régional du Cancer de Montpellier
🇫🇷Montpellier, France
Scroll for more (39 remaining)UCLA Center for East-West Medicine🇺🇸Los Angeles, California, United States