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)
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months
Number of Participants experiencing Serious Adverse Events (SAEs) as assessed by the investigator.
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months
Objective response rate (ORR)
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.
Time frame: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
Duration of response (DOR)
Time frame: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
Time to response (TTR)
Time from the start date of study drug to the first determination of an objective response by investigator per RECIST Version 1.1
Time frame: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
Progression-free survival (PFS)
Percentage of participants with best overall response of complete response, partial response, and stable disease by investigator per RECIST Version 1.1
Time frame: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
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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
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: Predose and immediately postdose
Observed maximum plasma concentration of zanidatamab during a sample interval (Cmax)
Time frame: Predose and immediately postdose
Observed time to maximum plasma concentration of zanidatamab during a sampling interval (tmax)
Time frame: Predose and immediately postdose
Terminal elimination half-life (t1/2) of zanidatamab
Time frame: Predose and immediately postdose
Area under the plasma concentration-time curve from time zero to the last measurable timepoint (AUC(0-t)) of zanidatamab
Time frame: Predose and immediately postdose
Apparent clearance after oral administration (CL/F) of zanidatamab
Time frame: Predose and immediately postdose
Presence of anti-zanidatamab-antibodies
Time frame: Predose and immediately postdose
Presence of zanidatamab neutralizing antibodies
Time frame: Predose and immediately postdose
Number of participants with AEs and SAEs 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