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New treatment option for Breast Cancer
Official title A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
ClinicalTrials.gov ID: NCT06695845
What this study is testing
What is Zanidatamab?
Zanidatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as ZW25, JZP598.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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 \ 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Prescott, Arizona, United States
- Littleton, Colorado, United States
- Fort Myers, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Chicago Ridge, Illinois, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Horsham, Pennsylvania, United States
- Knoxville, Tennessee, United States
- Nashville, Tennessee, United States
- Amarillo, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Roanoke, Virginia, United States
- Suwon, Gyeonggi-do, South Korea
- Hwasun-Eup, Hwasun-Gun, South Korea
- Gangnam-gu, Seoul, South Korea
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prescott, Arizona, United States; Littleton, Colorado, United States; Fort Myers, Florida, United States; Orlando, Florida, United States; St. Petersburg, Florida, United States; West Palm Beach, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.