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New antibody drug targets HER2 cancers in broad trial

NCT ID NCT06695845

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase 2 trial tests a drug called zanidatamab in about 200 adults with advanced HER2-positive cancers, including breast, lung, stomach, and others. Participants have already tried at least one standard treatment. The study measures how many tumors shrink or disappear. Zanidatamab is given by IV and aims to control the disease rather than cure it.

What this could mean

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

Active substance
zanidatamab (also called ZW25, JZP598, ZIIHERA®) - an antibody given by IV infusion
What this could lead to
If successful, this could provide a new treatment option for people with several types of HER2-positive cancers that have stopped responding to other therapies.
What could go wrong
This is a mid-stage trial with no control group, so results are preliminary. It may not work for all cancer types tested, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Inclusion Criteria: 1. Is at least 18 years of age inclusive at the time of signing the informed consent 2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required. 3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory. 4. All participants must have adequate tumor sample for submission to allow central HER2 testing. 5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) 6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has a life expectancy of at least 3 months, in the opinion of the investigator. 8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met: 1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS. 2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \< Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment \> 7 days prior to Cycle 1 Day 1. 3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention. 9. Adequate organ functions. 10. Females of childbearing potential must have a negative pregnancy test result. 11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control. Exclusion Criteria: 1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis. 2. Has uncontrolled or significant cardiovascular disease 3. Has ongoing toxicity related to prior cancer therapy 4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals. 5. Has known Human Immunodeficiency Virus (HIV) infection. 6. Has active hepatitis B or C infection. 7. Has an active SARS-CoV-2 infection. 8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab. 9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site. 10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study. 11. Prior treatment with HER2-targeted therapy (Cohort 1 only). 12. Has a history of trauma or major surgery 13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. 14. Received zanidatamab at any time prior to the current study. 15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations. 16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion. 17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy. 18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm gastroesophageal cancer malignant pancreatic neoplasm non-small cell lung carcinoma ovarian cancer pancreatic neoplasm salivary gland cancer transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Breast cancer Colorectal cancer Endometrial cancer Esophageal cancer Gastric cancer Gastroesophageal cancer HER-2 protein overexpression Non-small cell lung cancer Ovarian cancer Pancreatic cancer Salivary gland cancer Urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Oncologists

    WITHDRAWN

    Chicago Ridge, Illinois, 60415, United States

  • Alliance Cancer Specialists

    WITHDRAWN

    Horsham, Pennsylvania, 19044, United States

  • Arizona Oncology Associates, PC - NAHOA

    WITHDRAWN

    Prescott, Arizona, 86301, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Barbara Ann Karmanos Cancer Institute

    WITHDRAWN

    Detroit, Michigan, 48201, United States

  • Blue Ridge Cancer Care

    WITHDRAWN

    Roanoke, Virginia, 24014, United States

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun-Eup, Hwasun-Gun, 58115, South Korea

  • Florida Cancer Specialists - East

    WITHDRAWN

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists - Lake Nona

    ACTIVE_NOT_RECRUITING

    Orlando, Florida, 32827, United States

  • Florida Cancer Specialists - North

    WITHDRAWN

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists - South

    WITHDRAWN

    Fort Myers, Florida, 33901, United States

  • Hospital Regional Universitario de Malaga - Hospital General

    RECRUITING

    Málaga, 29010, Spain

  • Korea University Guro Hospital

    RECRUITING

    Guro-gu, Seoul, 04524, South Korea

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center Suwon

    RECRUITING

    Suwon, Gyeonggi-do, 10408, South Korea

  • Rocky Mountain Cancer Center

    RECRUITING

    Littleton, Colorado, 80120, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    RECRUITING

    Gangnam-gu, Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seoul, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Jongno-gu, Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seodaemun-gu, Seoul, 03722, South Korea

  • Tennessee Cancer Specialists

    WITHDRAWN

    Knoxville, Tennessee, 37909, United States

  • Texas Oncology - DFW

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology - San Antonio

    WITHDRAWN

    San Antonio, Texas, 78217, United States

  • Texas Oncology - West Texas

    WITHDRAWN

    Amarillo, Texas, 79124, United States

  • The Catholic University of Korea Seoul St. Mary's Hospital

    RECRUITING

    Seoul, 04524, South Korea

  • The Catholic University of Korea St Vincent's Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 10408, South Korea

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