A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors

Recruiting now · Phase 2

Conditions studied: Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Urothelial Carcinoma, Salivary Gland Cancer, Pancreatic Cancer, HER-2 Protein Overexpression

In brief

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.

Key facts

Study ID: NCT06695845
Run by: Jazz Pharmaceuticals
People needed: 200
Starts: 2025-01-14
Expected to finish: 2027-12-31
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is at least 18 years of age inclusive at the time of signing the informed consent
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.
HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
All participants must have adequate tumor sample for submission to allow central HER2 testing.
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)
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has a life expectancy of at least 3 months, in the opinion of the investigator.
Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:
Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
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.
Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
Adequate organ functions.
Females of childbearing potential must have a negative pregnancy test result.
Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

You may not qualify if…

Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
Has uncontrolled or significant cardiovascular disease
Has ongoing toxicity related to prior cancer therapy
Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
Has known Human Immunodeficiency Virus (HIV) infection.
Has active hepatitis B or C infection.
Has an active SARS-CoV-2 infection.
Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
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.
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.
Prior treatment with HER2-targeted therapy (Cohort 1 only).
Has a history of trauma or major surgery
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.
Received zanidatamab at any time prior to the current study.
Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
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.

Where it is running

Hospital Regional Universitario de Malaga - Hospital General — Málaga, Spain (enrolling)
Rocky Mountain Cancer Center — Littleton, Colorado, United States (enrolling)
Texas Oncology - DFW — Dallas, Texas, United States (enrolling)
MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
National Cancer Center Suwon — Suwon, Gyeonggi-do, South Korea (enrolling)
The Catholic University of Korea St Vincent's Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
Chonnam National University Hwasun Hospital — Hwasun-Eup, Hwasun-Gun, South Korea (enrolling)
Samsung Medical Center — Gangnam-gu, Seoul, South Korea (enrolling)
Korea University Guro Hospital — Guro-gu, Seoul, South Korea (enrolling)
Seoul National University Hospital — Jongno-gu, Seoul, South Korea (enrolling)
Severance Hospital — Seodaemun-gu, Seoul, South Korea (enrolling)
The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, South Korea (enrolling)
Asan Medical Center — Seoul, South Korea (enrolling)
Seoul National University Bundang Hospital — Seoul, South Korea (enrolling)
Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
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
Arizona Oncology Associates, PC - NAHOA — Prescott, Arizona, United States
Alliance Cancer Specialists — Horsham, Pennsylvania, United States
Tennessee Cancer Specialists — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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