Actively Recruiting
A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for Previously Treated HER2-expressing Solid Tumors
Led by Jazz Pharmaceuticals · Updated on 2026-04-09
200
Participants Needed
21
Research Sites
52 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
Researchers are evaluating zanidatamab, an intravenous drug, for treating adults with previously treated solid tumors that show high levels of HER2 protein (IHC 3+). This phase 2, open-label study focuses on participants whose tumors have progressed after prior systemic treatments and aims to assess the drug's safety and effectiveness. The study excludes certain cancers like biliary tract cancer and considers participants with various solid tumors such as breast, gastric, lung, and colorectal cancers. Participants will receive zanidatamab through intravenous infusion, with treatment details tailored to their specific tumor type and prior therapy history. The study includes cohorts with different prior treatment backgrounds, including those who have received HER2-targeted therapies and those who have not. Tumor samples will be centrally tested to confirm HER2 overexpression, and participants must have measurable disease for assessment. During the study, participants will undergo regular evaluations including imaging scans assessed by independent review and investigators to measure tumor response using RECIST 1.1 criteria. Researchers will monitor safety through adverse event reporting and laboratory tests, track drug levels and immune response, and assess quality of life related to side effects. The study duration for outcome assessment is up to 2.5 years for most measures, with overall survival followed up to 3.5 years.
CONDITIONS
Brief 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 informed consent
- Have locally advanced, unresectable, or metastatic solid tumors (excluding biliary tract cancer) that progressed after at least one prior systemic treatment
- No prior HER2-targeted therapy for Cohort 1; prior HER2-targeted therapy required for breast cancer (Cohort 2) and GEA (Cohort 3)
- HER2 overexpression (IHC 3+) confirmed by a central lab
- Provide adequate tumor sample for central HER2 testing
- Have at least one measurable lesion by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- History of treated, stable CNS metastases allowed if asymptomatic and meeting recovery 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 or requiring intravenous antibiotics, antivirals, or antifungals
- Known HIV infection
- Active hepatitis B or C infection
- Active SARS-CoV-2 infection
- History of life-threatening allergy to monoclonal antibodies or components of zanidatamab
- Serious medical or psychiatric conditions that impair treatment tolerance
- Any condition that would interfere with study participation or results
- Prior HER2-targeted therapy for Cohort 1
- History of trauma or major surgery
- Recent systemic antineoplastic or investigational therapy within 4 weeks or 5 half-lives before starting study
- Previous zanidatamab treatment
- Colorectal cancer patients with KRAS/NRAS or BRAF mutations
- NSCLC patients with ALK, EGFR mutations or ROS1 fusion
- Pregnant or breastfeeding women, or those planning pregnancy
- Prior or concurrent invasive malignancy other than the study disease that could affect safety or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2.5 years or until disease progression or discontinuation
Participants receive zanidatamab by intravenous infusion to treat HER2-expressing tumors.
Regular visits for treatment and assessments during the treatment period
Duration - Up to 3.5 years
Participants are monitored for safety, side effects, and overall survival after treatment ends.
Visits scheduled periodically during follow-up
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
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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