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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-26

Study Completion Date

2024-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer Gastric Cancer Gastroesophageal Junction Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1- Zanidatamab + Docetaxel

Zanidatamab intravenous (IV) infusion followed by docetaxel IV infusion first-line therapy once every three weeks (Q3W) in female participants with metastatic breast cancer

Group Type EXPERIMENTAL

Zanidatamab

Intervention Type BIOLOGICAL

Administered intravenously

Docetaxel

Intervention Type DRUG

Administered intravenously

Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy

Zanidatamab intravenous (IV) infusion followed by tislelizumab IV infusion and CAPOX chemotherapy (oral capecitabine + IV oxaliplatin) first-line therapy once every three weeks (Q3W) in participants with metastatic gastric / GEJ adenocarcinoma

Group Type EXPERIMENTAL

Zanidatamab

Intervention Type BIOLOGICAL

Administered intravenously

Tislelizumab

Intervention Type BIOLOGICAL

Administered intravenously

Capecitabine

Intervention Type DRUG

Administered orally

Oxaliplatin

Intervention Type DRUG

Administered intravenously

Interventions

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Zanidatamab

Administered intravenously

Intervention Type BIOLOGICAL

Docetaxel

Administered intravenously

Intervention Type DRUG

Tislelizumab

Administered intravenously

Intervention Type BIOLOGICAL

Capecitabine

Administered orally

Intervention Type DRUG

Oxaliplatin

Administered intravenously

Intervention Type DRUG

Other Intervention Names

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ZW25 BGB-A317

Eligibility Criteria

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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
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

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)
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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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The Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status

Guangdong Provincial Peoples Hospital Huifu Branch

Guangzhou, Guangdong, China

Site Status

The Third Hospital of Nanchang

Nanchang, Jiangxi, China

Site Status

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status