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Trial record 3 of 7 for:    zw25

Anti-HER2 Bispecific Antibody ZW25 Activity in Combination With Chemotherapy With/Without Tislelizumab

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ClinicalTrials.gov Identifier: NCT04276493
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE February 4, 2020
First Posted Date  ICMJE February 19, 2020
Last Update Posted Date April 23, 2021
Actual Study Start Date  ICMJE March 26, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • Number of Participants experiencing Adverse Events (AEs) [ Time Frame: Up to 12 months after the last dose of study drug. ]
  • Number of Participants experiencing Severe Adverse Events (SAEs) as assessed by the investigator. [ Time Frame: Up to 12 months after the last dose of study drug. ]
  • Objective response rate (ORR) [ Time Frame: Up to 12 months after the last dose of study drug or before the initiation of a new anticancer treatment, whichever occurs first. ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • Duration of response (DOR) [ Time Frame: Up to 36 Months ]
  • Time to response (TRR) [ Time Frame: Up to 36 Months ]
    Time from the start date of study drug to the first determination of an objective response by investigator per RECIST Version 1.1
  • Progression-free survival (PFS) [ Time Frame: Up to 36 Months ]
    Proportion of participants with best overall response of complete response, partial response, and stable disease by investigator per RECIST Version 1.1
  • Overall survival (OS) [ Time Frame: Up to 60 Months ]
    Time from the start date of study drug to the date of death due to any cause
  • Serum concentration of ZW25 as a function of time [ Time Frame: Predose and immediately postdose ]
  • Observed maximum plasma concentration during a sample interval (Cmax (ng/mL) [ Time Frame: Predose and immediately postdose ]
  • Observed time to maximum plasma concentration during a sampling interval (tmax(hour)) [ Time Frame: Predose and immediately postdose ]
  • Terminal elimination half-life (t1/2(hour)) [ Time Frame: Predose and immediately postdose ]
  • Area under the plasma concentration-time curve from time zero to the last measurable timepoint (AUC(0-t) (ng*h/mL)) [ Time Frame: Predose and immediately postdose ]
  • Apparent clearance after oral administration (CL/F(L/hr)) [ Time Frame: Predose and immediately postdose ]
  • Presence of anti-ZW25-antibodies [ Time Frame: Predose and immediately postdose ]
  • Presence of ZW25 neutralizing antibodies [ Time Frame: Predose and immediately postdose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-HER2 Bispecific Antibody ZW25 Activity in Combination With Chemotherapy With/Without Tislelizumab
Official Title  ICMJE Phase 1b/2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-HER2 Bispecific Antibody ZW25 in Combination With Chemotherapy With/Without Tislelizumab in Patients With Advanced HER2-positive Breast Cancer or Gastric/Gastroesophageal Junction Adenocarcinoma
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Gastric Cancer
  • Gastroesophageal Junction Cancer
Intervention  ICMJE
  • 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
    Other Name: BGB-A317
  • Drug: Capecitabine
    Administered as specified in the treatment arm
  • Drug: Oxaliplatin
    Administered as specified in the treatment arm
Study Arms  ICMJE
  • Experimental: Cohort 1- ZW25 + Docetaxel
    ZW25 intravenous (IV) infusion followed by docetaxel IV infusion first-line therapy once every three weeks (Q3W) in female participants with metastatic breast cancer
    Interventions:
    • Biological: ZW25
    • Drug: Docetaxel
  • Experimental: Cohort 2- ZW25 + Tiselizumab + Chemotherapy
    ZW25 intravenous (IV) infusion followed by tiselizumab IV infusion and CAPOX chemotherapy (oral capecitabine + IV oxaliplatin) first-line therapy once every three weeks (Q3W) in participants with metastatic gastric / GEJ adenocarcinoma
    Interventions:
    • Biological: ZW25
    • Biological: Tislelizumab
    • Drug: Capecitabine
    • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2025
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or uncontrolled brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before the first dose of study drug
  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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04276493
Other Study ID Numbers  ICMJE BGB-A317-ZW25-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vivian Li, MD BeiGene
PRS Account BeiGene
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP