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Can a Double-Pronged antibody outsmart HER2-Positive tumors?

NCT ID NCT04276493

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests an experimental drug called zanidatamab, which targets HER2, a protein that fuels certain breast and stomach cancers. Researchers give zanidatamab alongside chemotherapy, and sometimes with the immunotherapy tislelizumab, to people with advanced HER2-positive breast cancer or gastric/gastroesophageal junction cancer. The goal is to see whether the combination is safe and whether it shrinks tumors. The study is in early phases, so it focuses on side effects and preliminary signs of effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zanidatamab (an experimental bispecific antibody targeting HER2), given with chemotherapy (docetaxel, capecitabine, oxaliplatin) and sometimes tislelizumab (an immunotherapy)
What this could lead to
If it works, this combination could offer a new treatment option for advanced HER2-positive breast and stomach cancers, potentially shrinking tumors and delaying progression.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits are unproven. The drug combinations may cause side effects, and the results may not lead to a widely available treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

71 people

The number who actually took part.

Started

Mar 2020

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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) 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Gastric cancer Gastroesophageal junction cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 06273, South Korea

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong, 510120, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Korea University Guro Hospital

    Seoul, Seoul Teugbyeolsi, 08308, South Korea

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital East Campus

    Taipei, 100225, Taiwan

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Affiliated Hospital of Military Medical Sciences

    Beijing, Beijing Municipality, 100071, China

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330009, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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