What is zanidatamab studying for HER2-expressing solid tumors?

Zanidatamab is being studied to evaluate its effect in adults with previously treated solid tumors that overexpress HER2 protein, focusing on safety and tumor response. The trial aims to understand how this drug works in participants whose cancers have progressed after other treatments. Jazz Pharmaceuticals leads this research to explore treatment options for these patients.

Who may be eligible for this HER2-expressing solid tumor clinical trial?

Adults aged 18 years and older with solid tumors overexpressing HER2 at IHC 3+ may be eligible. Participants should have disease that progressed after prior treatments and meet health criteria like organ function and performance status. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this HER2-expressing solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered during participation.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06695845

Phase 2 Study of Zanidatamab for Previously Treated HER2-Expressing Solid Tumors Evaluating Safety and Effectiveness in Advanced Cancer

Led by Jazz Pharmaceuticals · Updated on 2026-07-10

200

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating zanidatamab for treating adults with previously treated solid tumors that overexpress the HER2 protein at a high level IHC 3. This Phase 2 study focuses on participants whose tumors have progressed after at least one prior systemic treatment and who have no other confirmed beneficial treatment options. The study excludes certain cancers like biliary tract cancer and considers prior HER2 therapy differently across tumor cohorts. Participants receive zanidatamab through intravenous infusion. The study includes a single treatment group with no placebo comparison. Treatment continues as per protocol with monitoring for responses and safety. The study collects tumor samples centrally to confirm HER2 status and requires measurable disease for evaluation. Various cohorts have specific prior treatment requirements. During the study, participants undergo assessments including tumor response evaluation by independent review and investigators using standard criteria RECIST 1.1. The trial monitors treatment safety, side effects, drug levels in the blood, and immune reactions to the drug. Participants will be followed for up to 2.5 years for response and safety, and overall survival is tracked for up to 3.5 years, with regular visits to assess health status and treatment effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at the time of consent
Locally advanced, unresectable, or metastatic solid tumors (excluding biliary tract cancer) with progression after at least one prior systemic treatment
No prior HER2-targeted therapy for Cohort 1; prior HER2 therapy allowed for breast and GEA cohorts with required prior trastuzumab deruxtecan
HER2 overexpression (IHC 3+) confirmed by central lab
Adequate tumor sample for central HER2 testing
At least one measurable lesion by RECIST 1.1
ECOG performance status of 0 or 1
Life expectancy of at least 3 months
Treated and stable CNS metastases allowed if meeting specific recovery and timing criteria
Adequate organ function
Negative pregnancy test for females of childbearing potential
Agreement to use two methods of birth control for females of childbearing potential and males with partners of childbearing potential

You will not qualify if you...

Known or suspected leptomeningeal disease or untreated brain metastasis
Uncontrolled or significant cardiovascular disease
Ongoing toxicity related to prior cancer therapy
Uncontrolled infection or requiring intravenous antibiotics, antivirals, or antifungals
Known HIV infection
Active hepatitis B or C infection
Active SARS-CoV-2 infection
History of life-threatening hypersensitivity to monoclonal antibodies or zanidatamab components
Serious medical or psychiatric conditions impairing treatment tolerance
Conditions that contraindicate participation or confound study results as judged by investigator
Prior HER2-targeted therapy in Cohort 1
History of trauma or major surgery
Systemic antineoplastic therapy within 4 weeks or 5 half-lives before study start
Previous zanidatamab treatment
Colorectal cancer with KRAS/NRAS and BRAF mutations
NSCLC with ALK, EGFR mutations or ROS1 fusion
Breastfeeding, pregnant, or planning pregnancy
Prior or concurrent invasive malignancy other than study disease interfering with safety or efficacy assessment

Research Team

Clinical Trial Disclosure & Transparency

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