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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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 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

  1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis. 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Zanidatamab treatment arm 		Eligible participants receiving zanidatamab treatment
  • Drug: Zanidatamab
    Administered by intravenous (IV) infusion
    Other names:
    • ZW25
    • JZP598
    • ZIIHERA®

Recruiting Locations

Arizona Oncology Associates, PC - NAHOA
Prescott 5309842, Arizona 5551752 86301

Rocky Mountain Cancer Center
Littleton 5429032, Colorado 5417618 80120

Florida Cancer Specialists - South
Fort Myers 4155995, Florida 4155751 33901

Florida Cancer Specialists - Lake Nona
Orlando 4167147, Florida 4155751 32827

Florida Cancer Specialists - North
St. Petersburg 4171563, Florida 4155751 33705

Florida Cancer Specialists - East
West Palm Beach 4177887, Florida 4155751 33401

Affiliated Oncologists
Chicago Ridge 4887492, Illinois 4896861 60415

Barbara Ann Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

Alliance Cancer Specialists
Horsham 5194302, Pennsylvania 6254927 19044

Tennessee Cancer Specialists
Knoxville 4634946, Tennessee 4662168 37909

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

Texas Oncology - West Texas
Amarillo 5516233, Texas 4736286 79124

Texas Oncology - DFW
Dallas 4684888, Texas 4736286 75246

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Texas Oncology - San Antonio
San Antonio 4726206, Texas 4736286 78217

Blue Ridge Cancer Care
Roanoke 4782167, Virginia 6254928 24014

More Details

NCT ID
NCT06695845
Status
Recruiting
Sponsor
Jazz Pharmaceuticals

Study Contact

Clinical Trial Disclosure & Transparency
215-832-3750
ClinicalTrialDisclosure@JazzPharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center