RecruitingPhase 2NCT06695845

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

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)


Sponsor

Jazz Pharmaceuticals

Enrollment

200 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a drug called zanidatamab — a bispecific antibody that targets HER2-overexpressing tumors — in patients with advanced solid cancers (excluding biliary tract cancers) that have high HER2 protein expression. HER2 is a protein that drives some cancers to grow aggressively, and this drug is designed to block it from two angles simultaneously. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor (not biliary tract cancer) that overexpresses HER2 (confirmed as IHC 3+ by a central lab) - Your cancer has progressed after at least one prior systemic treatment - If you have breast cancer or stomach/esophageal cancer, prior HER2-targeted therapy (including trastuzumab deruxtecan) is required - You have at least one measurable tumor and are in reasonably good physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has not been confirmed as HER2 IHC 3+ by the designated lab - For Cohort 1 (non-breast/non-stomach cancers): you have had prior HER2-targeted therapy - You have unstable brain metastases - Your organ function or health status is insufficient to tolerate treatment - You have had prior HER2 ADC therapy (in certain cohorts) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanidatamab

Administered by intravenous (IV) infusion


Locations(21)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06695845


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