Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04276493
Other study ID # BGB-A317-ZW25-101
Secondary ID CTR20210237
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 26, 2020
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of ZW25 in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and ZW25 in combination with tislelizumab and chemotherapy in participants with HER2-positive gastric/gastroesophageal Junction (GEJ) adenocarcinoma


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 71
Est. completion date December 31, 2026
Est. primary completion date December 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: 1. Disease diagnosis and prior treatment: 1. Cohort 1 (the first-line breast cancer treatment cohort): - Female participants with histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the breast and candidate for chemotherapy. Locally recurrent disease must not be amenable to resection with curative intent. - Human epidermal growth factor receptor 2 (HER2) IHC 3+ or in situ hybridization positive on the archival tumor tissue or fresh biopsy sample. - Have not received previous systemic anticancer therapy for locally advanced unresectable or metastatic disease. 2. Cohort 2 (the first-line gastric/gastroesophageal junction adenocarcinoma treatment cohort): - Histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction - HER2 IHC 3+ or HER2 IHC 2+ together with in situ hybridization positive on the archival tumor tissue or fresh biopsy sample. - Have not received previous systemic anticancer therapy for locally advanced unresectable or metastatic disease, including any approved or investigational estimated glomerular filtration rate (EGFR) or anti-HER2 agents or vaccines, cytotoxic chemotherapy or checkpoint inhibitors 2. At least 1 measurable lesion as defined per RECIST Version 1.1 3. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1 4. Adequate organ function as indicated by the following laboratory values during screening: 5. Left ventricular ejection fraction (LVEF) = 50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA) (echocardiogram is the preferred method) within 28 days before the first dose of study drug Key Exclusion Criteria: 1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 2. History of approved or investigative tyrosine kinase/HER inhibitors in any treatment setting a. except trastuzumab with or without pertuzumab used in neoadjuvant or adjuvant setting for Cohort 1 3. Active leptomeningeal disease, untreated or uncontrolled brain metastasis 4. Any active malignancy = 2 years before the first dose of study drug, except for the specific cancer under investigation in this trial and any localized cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast) 5. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before the first dose of study drug Note: Participants who are currently or have previously been on any of the following steroid regimens are not excluded: 1. Adrenal replacement steroid (dose = 10 mg daily of prednisone or equivalent) 2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption 3. Short course (= 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Intervention

Biological:
ZW25
Administered as specified in the treatment arm
Drug:
Docetaxel
Administered as specified in the treatment arm
Biological:
Tislelizumab
Administered as specified in the treatment arm
Drug:
Capecitabine
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China The fifth Medical Center, Chinese PLA General Hospital Beijing Beijing
China Jilin Cancer Hospital Changchun Jilin
China Chongqing Cancer Hospital Chongqing
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China The Third Hospital of Nanchang Nanchang
China Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology Shenyang Liaoning
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital, Yonsei University Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul Saint Mary's Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Seoul
Taiwan Chang Gung Memorial Hospital, Kaohsiung Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants experiencing Adverse Events (AEs) Up to 12 months after the last dose of study drug.
Primary Number of Participants experiencing Severe Adverse Events (SAEs) as assessed by the investigator. Up to 12 months after the last dose of study drug.
Primary Objective response rate (ORR) Defined as the proportion 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. Up to 12 months after the last dose of study drug or before the initiation of a new anticancer treatment, whichever occurs first.
Secondary Duration of response (DOR) Up to 36 Months
Secondary Time to response (TRR) Time from the start date of study drug to the first determination of an objective response by investigator per RECIST Version 1.1 Up to 36 Months
Secondary Progression-free survival (PFS) Proportion of participants with best overall response of complete response, partial response, and stable disease by investigator per RECIST Version 1.1 Up to 36 Months
Secondary Overall survival (OS) Time from the start date of study drug to the date of death due to any cause Up to 60 Months
Secondary Serum concentration of ZW25 as a function of time Predose and immediately postdose
Secondary Observed maximum plasma concentration during a sample interval (Cmax (ng/mL) Predose and immediately postdose
Secondary Observed time to maximum plasma concentration during a sampling interval (tmax(hour)) Predose and immediately postdose
Secondary Terminal elimination half-life (t1/2(hour)) Predose and immediately postdose
Secondary Area under the plasma concentration-time curve from time zero to the last measurable timepoint (AUC(0-t) (ng*h/mL)) Predose and immediately postdose
Secondary Apparent clearance after oral administration (CL/F(L/hr)) Predose and immediately postdose
Secondary Presence of anti-ZW25-antibodies Predose and immediately postdose
Secondary Presence of ZW25 neutralizing antibodies Predose and immediately postdose
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A