Actively Recruiting
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Led by Jazz Pharmaceuticals · Updated on 2026-04-09
200
Participants Needed
21
Research Sites
154 weeks
Total Duration
On this page
Sponsors
J
Jazz Pharmaceuticals
Lead Sponsor
J
Jazz Pharmaceuticals Ireland Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of consent
- Locally advanced, unresectable, or metastatic solid tumors (excluding biliary tract cancer) with progression after at least 1 prior systemic treatment and no effective treatment options
- For Cohort 1, no prior HER2-targeted therapy; for Cohorts 2 and 3 (breast cancer and GEA), prior HER2 therapy allowed and trastuzumab deruxtecan required
- HER2 overexpression (IHC 3+) confirmed by central lab
- Adequate tumor sample available for central HER2 testing
- At least 1 measurable lesion by RECIST 1.1 per Independent Central Review
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Participants with treated, stable CNS metastases allowed if meeting specific recovery and timing criteria
- Adequate organ function
- Negative pregnancy test for females of childbearing potential
- Willingness to use two methods of birth control for females of childbearing potential and males with partners of childbearing potential
You will not qualify if you...
- Known or suspected leptomeningeal disease or untreated brain metastasis
- Uncontrolled or significant cardiovascular disease
- Ongoing toxicity from prior cancer therapy
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Known HIV infection
- Active hepatitis B or C infection
- Active SARS-CoV-2 infection
- History of life-threatening hypersensitivity to monoclonal antibodies or zanidatamab components
- Serious medical or psychiatric conditions affecting treatment tolerance
- Conditions contraindicating participation or confounding study results as judged by investigator
- Prior HER2-targeted therapy in Cohort 1
- History of trauma or major surgery
- Systemic antineoplastic therapy or investigational therapy within 4 weeks or 5 half-lives before Cycle 1 Day 1
- Prior zanidatamab treatment
- Colorectal cancer patients with known KRAS/NRAS and BRAF mutations
- NSCLC patients with known ALK, EGFR mutations, or ROS1 fusion
- Pregnant or breastfeeding females, and participants planning pregnancy
- Prior or concurrent invasive malignancy other than study disease that may interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Arizona Oncology Associates, PC - NAHOA
Prescott, Arizona, United States, 86301
Actively Recruiting
2
Rocky Mountain Cancer Center
Littleton, Colorado, United States, 80120
Actively Recruiting
3
Florida Cancer Specialists - South
Fort Myers, Florida, United States, 33901
Actively Recruiting
4
Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
5
Florida Cancer Specialists - North
St. Petersburg, Florida, United States, 33705
Actively Recruiting
6
Florida Cancer Specialists - East
West Palm Beach, Florida, United States, 33401
Actively Recruiting
7
Affiliated Oncologists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
8
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
9
Alliance Cancer Specialists
Horsham, Pennsylvania, United States, 19044
Actively Recruiting
10
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Actively Recruiting
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Texas Oncology - West Texas
Amarillo, Texas, United States, 79124
Actively Recruiting
13
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78217
Actively Recruiting
16
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
17
Samsung Medical Center
Gangnam-gu, Seoul, South Korea, 06351
Actively Recruiting
18
Seoul National University Hospital
Jongno-gu, Seoul, South Korea, 03080
Actively Recruiting
19
Severance Hospital
Seodaemun-gu, Seoul, South Korea, 03722
Actively Recruiting
20
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
21
Seoul National University Bundang Hospital
Seoul, South Korea, 13620
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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