NCT06695845 · Jazz Pharmaceuticals
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
What this study is about
The purpose of this study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Zanidatamab
Administered by intravenous (IV) infusion
Primary outcome measures
Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR
Time frame: Up to 2.5 years
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 E
Where
- Prescott, Arizona
- Littleton, Colorado
- Fort Myers, Florida
- Orlando, Florida
- St. Petersburg, Florida
- West Palm Beach, Florida
- Chicago Ridge, Illinois
- Detroit, Michigan
- New York, New York
- Horsham, Pennsylvania
- Knoxville, Tennessee
- Nashville, Tennessee
And 5 more locations — see the full list below.
Collaborators
Jazz Pharmaceuticals Ireland Limited
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations