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Breast CancerPhase 2NCT06695845

A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors

A Phase 2 study testing Zanidatamab in people with Breast Cancer and Gastric Cancer, run by Jazz Pharmaceuticals at 42 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Gastric Cancer, Esophageal Cancer
What is being tested?
Zanidatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
42 sitesin 4 countries
Study dates
14 Jan 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is at least 18 years of age inclusive at the time of signing the informed consent
  • 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.
  • HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
  • All participants must have adequate tumor sample for submission to allow central HER2 testing.
  • 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)
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Has a life expectancy of at least 3 months, in the opinion of the investigator.
  • Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:
  • Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
  • 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.
  • Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
  • Adequate organ functions.
  • Females of childbearing potential must have a negative pregnancy test result.
  • Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Who cannot join

  • Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
  • Has uncontrolled or significant cardiovascular disease
  • Has ongoing toxicity related to prior cancer therapy
  • Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
  • Has known Human Immunodeficiency Virus (HIV) infection.
  • Has active hepatitis B or C infection.
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  • Has an active SARS-CoV-2 infection.
  • Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
  • 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.
  • 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.
  • Prior treatment with HER2-targeted therapy (Cohort 1 only).
  • Has a history of trauma or major surgery
  • 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.
  • Received zanidatamab at any time prior to the current study.
  • Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
  • Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
  • Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
  • 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.

Trial locations and contacts

42 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

42 sites in 4 countries

United States19 sites, 7 recruiting

  • Texas Oncology - West Texas

    Amarillo, Texas, 79124

    Withdrawn

  • Affiliated Oncologists

    Chicago Ridge, Illinois, 60415

    Withdrawn

  • Texas Oncology - DFW

    Dallas, Texas, 75246

    Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Withdrawn

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901

    Withdrawn

  • Alliance Cancer Specialists

    Horsham, Pennsylvania, 19044

    Withdrawn

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

    Withdrawn

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042

    Recruiting

  • Rocky Mountain Cancer Center

    Littleton, Colorado, 80120

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Florida Cancer Specialists - Lake Nona

    Orlando, Florida, 32827

    Active, not recruiting

  • Arizona Oncology Associates, PC - NAHOA

    Prescott, Arizona, 86301

    Withdrawn

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

    Withdrawn

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78217

    Withdrawn

  • Florida Cancer Specialists - North

    St. Petersburg, Florida, 33705

    Withdrawn

  • Florida Cancer Specialists - East

    West Palm Beach, Florida, 33401

    Withdrawn

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

South Korea10 sites, 10 recruiting

  • Samsung Medical Center

    Gangnam-gu, Seoul, 06351

    Recruiting

  • Korea University Guro Hospital

    Guro-gu, Seoul, 04524

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-Eup, Hwasun-Gun, 58115

    Recruiting

  • Seoul National University Hospital

    Jongno-gu, Seoul, 03080

    Recruiting

  • Severance Hospital

    Seodaemun-gu, Seoul, 03722

    Recruiting

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

    Seoul, 04524

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Seoul National University Bundang Hospital

    Seoul, 13620

    Recruiting

  • National Cancer Center Suwon

    Suwon, Gyeonggi-do, 10408

    Recruiting

  • The Catholic University of Korea St Vincent's Hospital

    Suwon, Gyeonggi-do, 10408

    Recruiting

Other trials in South Korea

Spain8 sites, 8 recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Insular Gran Canarias

    Las Palmas, Las Palmas de Gran Canarias, 35016

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • INCLIVA, Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

Georgia5 sites, 5 recruiting

  • JSC Vian- Krystyna Kiel Oncology Center

    Kutaisi, 4600

    Recruiting

  • LTD Todua Clinic

    Tbilisi, 0112

    Recruiting

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

    Tbilisi, 0144

    Recruiting

  • Cancer Research Centre

    Tbilisi, 0186

    Recruiting

  • LTD Caucasus Medical Centre

    Tbilisi, 0186

    Recruiting

Other trials in Georgia

About this study

Official title: A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.

Being tested
Zanidatamab
Keywords
JZP598, ZW25, HER2 IHC 3+ Overexpression Solid Tumors
Medical subject headings
Breast Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanidatamabDrug

    Also called ZW25, JZP598, ZIIHERA®

    Administered by intravenous (IV) infusion

Study groups in NCT06695845
Study groupRoleWhat they receive
Zanidatamab treatment armExperimentalEligible participants receiving zanidatamab treatment
Receives: Drug: Zanidatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR

    The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Measured: Up to 2.5 years

Secondary outcomes (19)

  1. Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR

    ICR assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause.

    Measured: Up to 2.5 years

  2. cORR by RECIST Version 1.1, as assessed by Investigator

    Investigator assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Measured: Up to 2.5 years

  3. Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator

    Investigator assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause.

    Measured: Up to 2.5 years

  4. Time to Response (TTR), as assessed by ICR

    ICR assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1.

    Measured: Up to 2.5 years

  5. Time to Response (TTR), as assessed by Investigator

    Investigator assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1.

    Measured: Up to 2.5 years

  6. Disease control rate (DCR), as assessed by ICR

    ICR assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria

    Measured: Up to 2.5 years

  7. Disease control rate (DCR), as assessed by Investigator

    Investigator assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria

    Measured: Up to 2.5 years

  8. Progression Free Survival (PFS), as assessed by ICR

    PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by ICR according to RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: Up to 2.5 years

  9. Progression Free Survival (PFS), as assessed by Investigator

    PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by Investigator according to RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: Up to 2.5 years

  10. Overall Survival (OS)

    OS is defined as the time in months from the first dosing date to the date of death due to any cause.

    Measured: Up to 3.5 years

  11. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) As Graded by NCI CTCAE Version 5.0

    Measured: Up to 2.5 years

  12. Number of Participants With Dose Reductions

    Measured: Up to 2.5 years

  13. Number of Participants Discontinuing Study Treatment Due to TEAEs

    Measured: Up to 2.5 years

  14. Serum Concentrations of Zanidatamab

    Measured: Up to 2.5 years

  15. Number of Participants Positive for Anti-drug Antibodies to Zanidatamab

    Measured: Up to 2.5 years

  16. Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE)

    Measured: Up to 2.5 years

  17. Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library

    Measured: Up to 2.5 years

  18. Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)

    Measured: Up to 2.5 years

  19. Percentage of time when participants on treatment reported a high side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start14 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06695845
Sponsor's protocol ID
JZP598-206
Other IDs
2024-516551-41-00
Status last verified
Nov 2026
First submitted
16 Nov 2024
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanidatamab in people with Breast Cancer and Gastric Cancer, run by Jazz Pharmaceuticals at 42 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, South Korea, Spain, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR (time frame: Up to 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06695845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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