The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of zanidatamab in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and zanidatamab in combination with tislelizumab and chemotherapy in participants with HER2-positive gastric/gastroesophageal Junction (GEJ) adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Administered intravenously
Administered intravenously
Administered intravenously
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, China
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose - resulted in death, - was life threatening, - required hospitalization or prolongation of existing hospitalization, - resulted in disability/incapacity, - was a congenital anomaly/birth defect.
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 42 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who had a best overall response of complete response or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Response was assessed every 6 weeks from cycle 1 day 1 for the first 36 weeks and then every 12 weeks thereafter; maximum time on study follow-up was 42months.
Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death, whichever occurred first.
Time frame: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 42 months
Time to Response (TTR)
Time to response is defined as the time from the start date of study treatment to the first determination of an objective response assessed by investigator per RECIST v 1.1.
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Administered orally
Administered intravenously
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
...and 11 more locations
Time frame: From the start date of study treatment to the first documentation of response, whichever occurs first, up to approximately 42 months
Progression-free Survival (PFS)
PFS is defined as the time from the start date of study drug to the date of the first objectively documented tumor progression assessed by investigator per RECIST Version 1.1 or death, whichever occurred first.
Time frame: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 42 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR, and stable disease by investigator per RECIST Version 1.1. BOR is the best response recorded from the start of the study drug treatment until the end of treatment taking into account any requirement for confirmation.
Time frame: Response was assessed every 6 weeks from cycle 1 day 1 for the first 36 weeks and then every 12 weeks thereafter; maximum time on study follow-up was 42 months.
Overall Survival (OS)
Time from the start date of study drug to the date of death due to any cause.
Time frame: From the start date of study treatment to the documented death date or the last known alive date, up to approximately 41 months
Serum Concentration of Zanidatamab as a Function of Time
Time frame: Day 1 end of infusion of Cycle 1, 2, 5, 9, 17, 26 and 35. Each cycle is 21 days
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Timepoint (AUC(0-t)) of Zanidatamab
Time frame: Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Observed Maximum Plasma Concentration of Zanidatamab During a Sample Interval (Cmax)
Time frame: Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Observed Time to Maximum Plasma Concentration of Zanidatamab During a Sampling Interval (Tmax)
Time frame: Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Terminal Elimination Half-life (t1/2) of Zanidatamab
Time frame: Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Apparent Clearance After Oral Administration (CL/F) of Zanidatamab
Time frame: Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose
Number of Participants With Anti-zanidatamab Antibodies
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 42 months
Number of Participants With AEs and SAEs in Participants Who Entered the Long-term Extension Period
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 51 months