The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow, unresectable, or metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Intravenous administration as determined by treatment arm.
Intravenous administration as determined by treatment arm.
Part 1: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Adverse event(AE): any untoward medical occurrence in a participant administered pharmaceutical product (PP) and which does not necessarily have a causal relationship with the treatment.AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding, for example),symptom,or disease temporally associated with the use of PP, whether or not considered related to the PP.Pre-existing conditions which worsen during study are also considered as AEs.SAE:any AE that fulfilled any of following criteria:fatal,life-threatening,required inpatient hospitalisation or prolongation of existing hospitalization,resulted in persistent or significant disability/incapacity,was congenital anomaly/birth defect, medically significant or required intervention to prevent any of the other outcomes listed here. TEAEs:AEs with start or worsening date during the on-treatment period(from 1st dose date of trial intervention to 47 days after the last dose date of trial intervention).
Time frame: Up to approximately 4.5 years
Part 2: Objective Response Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v.1.1) as Assessed by the Investigator
Objective response is defined as participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1.
Time frame: Up to approximately 4.5 years
Part 1: Objective Response Per RECIST v.1.1 as Assessed by the Investigator
Objective response is defined as participants with a BOR of confirmed CR or confirmed PR, as assessed by investigator per RECIST v1.1.
Time frame: Up to approximately 6 years
Part 2: Number of Participants With at Least One TEAE and SAE
AE: any untoward medical occurrence in a participant administered pharmaceutical product (PP) and which does not necessarily have a causal relationship with the treatment.AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding, for example),symptom,or disease temporally associated with the use of PP, whether or not considered related to the PP.Pre-existing conditions which worsen during study are also considered as AEs.SAE:any AE that fulfilled any of following criteria:fatal,life-threatening,required inpatient hospitalisation or prolongation of existing hospitalization,resulted in persistent or significant disability/incapacity,was congenital anomaly/birth defect, medically significant or required intervention to prevent any of the other outcomes listed here. TEAEs:AEs with start or worsening date during the on-treatment period(from 1st dose date of trial intervention to 47 days after the last dose date of trial intervention).
Time frame: Up to approximately 6 years
Parts 1 and 2: Disease Control Per RECIST v.1.1 as Assessed by the Investigator
Disease control is defined as participants with a BOR of confirmed CR, confirmed PR, or SD per RECIST v1.1.
Time frame: Up to approximately 6 years
Parts 1 and 2: Duration of Response (DoR) Per RECIST v.1.1 as Assessed by the Investigator
DoR is defined as the time (month) from date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression or death due to any cause.
Time frame: Up to approximately 6 years
Parts 1 and 2: Clinical Benefit Per RECIST v.1.1 as Assessed by Investigator
Clinical benefit is defined as participants with a BOR of confirmed CR, confirmed PR, or SD lasting ≥183 days, per RECIST v1.1.
Time frame: Up to approximately 6 years
Parts 1 and 2: Progression-free Survival (PFS) Per RECIST v.1.1 as Assessed by Investigator
PFS by investigator is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause.
Time frame: Up to approximately 6 years
Parts 1 and 2: Time to Response (TTR) Per RECIST v.1.1 as Assessed by Investigator
TTR is defined as the time (months) from the start date of study treatment to the date of the first documentation of response (CR or PR). TTR will be calculated for responders only.
Time frame: Up to approximately 6 years
Parts 1 and 2: Overall Survival (OS)
OS is defined as the time (month) from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 6 years
Part 1: Maximum Serum Concentration (Cmax) of Anti-HER3 Antibody Conjugate Deruxtecan (HER3-ac-DXd)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Cmax of Total Anti-HER3 Antibody Liquid Chromatography-mass Spectrometry (LC-MS)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Cmax of T-DXd
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Cmax of Total Anti-HER2 Antibody
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Cmax of Released Payload (DXd)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Trough Serum Concentration (Ctrough) of Anti-HER3-ac-DXd
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Ctrough of Total Anti-HER3 antibody LC-MS
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Ctrough of T-DXd
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Ctrough of Total Anti-HER2 Antibody
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Ctrough of Released Payload (DXd)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Time to Reach Maximum Serum Concentration (Tmax) of Anti-HER3-ac-DXd
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Tmax of Total Anti-HER3 Antibody LC-MS
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Tmax of T-DXd
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Tmax of Total Anti-HER2 Antibody
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 1: Tmax of Released Payload (DXd)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Part 2: Correlation Between HER3 Protein Expression and Efficacy
HER3 protein expression in tumor tissue as determined by immunohistochemistry (IHC) and correlation with ORR, DoR, and PFS.
Time frame: Up to approximately 6 years
Part 2: Correlation Between HER2 Protein Expression and Efficacy
HER2 protein expression in tumor tissue as determined by IHC and correlation with ORR, DoR, and PFS.
Time frame: Up to approximately 6 years
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