A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
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)
2 other identifiers
interventional
200
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2025
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2024
CompletedFirst Posted
Study publicly available on registry
November 19, 2024
CompletedStudy Start
First participant enrolled
January 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 9, 2026
April 1, 2026
2 years
November 16, 2024
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Up to 2.5 years
Secondary Outcomes (19)
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR
Up to 2.5 years
cORR by RECIST Version 1.1, as assessed by Investigator
Up to 2.5 years
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator
Up to 2.5 years
Time to Response (TTR), as assessed by ICR
Up to 2.5 years
Time to Response (TTR), as assessed by Investigator
Up to 2.5 years
- +14 more secondary outcomes
Study Arms (1)
Zanidatamab treatment arm
EXPERIMENTALEligible participants receiving zanidatamab treatment
Interventions
Administered by intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jazz Pharmaceuticalslead
- Jazz Pharmaceuticals Ireland Limitedcollaborator
Study Sites (21)
Arizona Oncology Associates, PC - NAHOA
Prescott, Arizona, 86301, United States
Rocky Mountain Cancer Center
Littleton, Colorado, 80120, United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists - Lake Nona
Orlando, Florida, 32827, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401, United States
Affiliated Oncologists
Chicago Ridge, Illinois, 60415, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology - West Texas
Amarillo, Texas, 79124, United States
Texas Oncology - DFW
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78217, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Samsung Medical Center
Gangnam-gu, Seoul, 06351, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, 03080, South Korea
Severance Hospital
Seodaemun-gu, Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Seoul National University Bundang Hospital
Seoul, 13620, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2024
First Posted
November 19, 2024
Study Start
January 14, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.