A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
NCT ID: NCT06695845
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-01-14
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zanidatamab treatment arm
Eligible participants receiving zanidatamab treatment
Zanidatamab
Administered by intravenous (IV) infusion
Interventions
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Zanidatamab
Administered by intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Has a life expectancy of at least 3 months, in the opinion of the investigator.
8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:
1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
2. 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.
3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
9. Adequate organ functions.
10. Females of childbearing potential must have a negative pregnancy test result.
11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion Criteria
2. Has uncontrolled or significant cardiovascular disease
3. Has ongoing toxicity related to prior cancer therapy
4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
5. Has known Human Immunodeficiency Virus (HIV) infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection.
8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
9. 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.
10. 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.
11. Prior treatment with HER2-targeted therapy (Cohort 1 only).
12. Has a history of trauma or major surgery
13. 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.
14. Received zanidatamab at any time prior to the current study.
15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
18. 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.
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals Ireland Limited
INDUSTRY
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Arizona Oncology Associates, PC - NAHOA
Prescott, Arizona, United States
Rocky Mountain Cancer Center
Littleton, Colorado, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Affiliated Oncologists
Chicago Ridge, Illinois, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - West Texas
Amarillo, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Samsung Medical Center
Gangnam-gu, Seoul, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Severance Hospital
Seodaemun-gu, Seoul, South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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2024-516551-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
JZP598-206
Identifier Type: -
Identifier Source: org_study_id