BB-1701
DrugBB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).
NCT Number: NCT06188559
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
CHU Besançon - Hôpital Jean Minjoz, Besançon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).
Time frame: 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.
Time frame: Baseline up to 35 months
Clinical laboratory parameters includes hematology, chemistry, and urinalysis.
Time frame: Baseline up to 35 months
Vital sign parameters includes systolic and diastolic blood pressure (BP), pulse, respiratory rate, body temperature.
Time frame: Baseline up to 35 months
Number of participants with clinically significant 12-lead ECGs values will be reported.
Time frame: Baseline up to 35 months
Number of participants with ECOG PS will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: Baseline up to 35 months
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 35 months
Clinical laboratory parameters includes hematology, chemistry, and urinalysis.
Time frame: Baseline up to 35 months
Vital sign parameters includes systolic and diastolic BP, pulse, respiratory rate, body temperature.
Time frame: Baseline up to 35 months
Number of participants with clinically significant 12-lead ECGs values will be reported.
Time frame: Baseline up to 35 months
Number of participants with ECOG PS will be reported.
Eisai Inc.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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