Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA

NCT07780968 | Not Yet Recruiting FDA Drug

• 1 other identifier: JZP598-401
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) (HER2+ la/m GEA).

Conditions

Esophageal Cancer; GastroEsophageal Cancer; Gastroesophageal-junction Cancer; HER2-positive Gastric Cancer; Stomach Cancer

Keywords

JZP598; ZIIHERA; Zanidatamab; GEA; HER2-positive gastroesophageal cancer; HER2-positive gastric cancer; HER2-positive esophageal cancer; HER2-positive GEA; HER2-positive stomach cancer; HER2-positive gastroesophageal junction cancer

Outcome Measures

Primary Outcomes (18)

• Average age of participants

  Baseline

• Patient demographics

  The number of participants at each demographic category: sex, race and ethnicity

  Baseline

• Clinical characteristics

  Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and gastrointestinal symptoms

  Baseline

• Average BMI

  Participants' average body mass index (BMI) in kilogram per square meters

  Baseline

• Average BSA

  Participants' average body surface area (BSA) in square meters

  Baseline

• Heart Function

  Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage

  Baseline

• Diagnostic history

  Number of participants at each initial diagnosis stage, TNM (tumor, nodes and metastasis) and clinical staging (metastatic, locally advanced, unresectable), disease subtype (gastric, esophageal or gastroesophageal) and metastatic sites by location

  Baseline

• Treatment history

  Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments

  Baseline

• Biomarkers

  Number of participants at each Programmed death-ligand 1 (PD-L1) expression category (through tumor area positivity (TAP) and combined positive score (CPS) scoring), HER2 amplification and expression results status via immunohistochemistry (IHC) or next generation sequencing (NGS).

  Baseline

• Number of participants taking a treatment in combination with first line zanidatamab-containing therapy

  Number of participants who took chemotherapy or immunotherapy in combination with first line zanidatamab-containing therapy

  Up to 5 years

• Average dose of treatment

  The average dose of zanidatamab per cycle and first line zanidatamab-containing therapy

  Up to 5 years

• Cycles of treatment

  Number of planned cycles of first line zanidatamab-containing therapy and actual number of cycles of first line zanidatamab-containing therapy

  Up to 5 years

• Average duration of first line zanidatamab-containing therapy

  Up to 5 years

• Number of participants at each HER2 status results after initiation of first line zanidatamab-containing therapy

  Up to 5 years

• Average chemotherapy dose adjustment

  Up to 5 years

• Duration of treatment interruption

  Up to 5 years

• Number of participants at each subsequent line of therapy after treatment discontinuation

  Up to 5 years

• Reason of treatment adjustment

  Number of participants at each reason for treatment discontinuation, interruption and/or chemotherapy dose adjustment

  Up to 5 years

Secondary Outcomes (18)

• Incidence of AESI

  Up to 5 years

• Duration of the AESI

  Up to 5 years

• Time (by treatment cycle) for the onset of AESI

  Up to 5 years

• Time (by treatment cycle) of dose adjustment

  Up to 5 years

• Number of participants that adhered to prescribed diarrhea prophylaxis

  Up to 5 years

Study Arms (1)

Zanidatamab-containing Therapy

Participants with HER2-positive locally advanced or metastatic GEA initiating a zanidatamab-containing therapy as first line treatment as part of standard-of-care treatment

Drug: Zanidatamab

Interventions

Zanidatamab DRUG

Administered via intravenous (IV) infusion

Also known as: ZW25, JZP598, ZIIHERA®

Zanidatamab-containing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll approximately 300 male and female participants, aged 18 years or older in the United States, diagnosed with HER2-positive locally advanced or metastatic GEA with a plan to initiate a 1L zanidatamab-containing therapy.

You may qualify if:

• Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA
• Documented plan to initiate a zanidatamab-containing therapy as 1L treatment
• Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions
• years of age or older on the date of initiating 1L zanidatamab-containing therapy

You may not qualify if:

• Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program
• Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA
• Received the first infusion of zanidatamab prior to providing study consent
• For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (2)

UCI Health - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of Texas - MD Anderson Cancer Center Gastrointestinal Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

zanidatamab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)