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A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510319-20-00
Acronym
ZWI-ZW25-301
Enrollment
251
Registered
2024-10-07
Start date
2021-10-21
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Adenocarcinoma (GEA)

Brief summary

●Progression-free survival (PFS) by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), assessed by blinded independent central review (BICR), ●Overall survival (OS) The primary PFS analysis will be performed once the target event count has been reached for each comparison. This is estimated to occur 7 months after the last subject is randomized. At this time, interim analyses of OS will be performed.

Detailed description

●Confirmed objective response rate (ORR) by RECIST 1.1, assessed by BICR, ●Duration of response (DOR) by RECIST 1.1, assessed by BICR, ●PFS by RECIST 1.1, per investigator assessment, ●Change from baseline in health economics and outcomes research / patient-reported outcomes (HEOR/PRO) parameters, ●Serum concentration and PK parameters for zanidatamab, ●Serum concentrations for tislelizumab

Interventions

DRUGLOPERAMIDE
DRUGTRASTUZUMAB
DRUGCAPECITABINE
DRUGTislelizumab
DRUGOxaliplatin 5 mg/ml concentrate for solution for infusion
DRUGJZP598

Sponsors

Jazz Pharmaceuticals Ireland Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
●Progression-free survival (PFS) by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), assessed by blinded independent central review (BICR), ●Overall survival (OS) The primary PFS analysis will be performed once the target event count has been reached for each comparison. This is estimated to occur 7 months after the last subject is randomized. At this time, interim analyses of OS will be performed.—

Secondary

MeasureTime frame
●Confirmed objective response rate (ORR) by RECIST 1.1, assessed by BICR, ●Duration of response (DOR) by RECIST 1.1, assessed by BICR, ●PFS by RECIST 1.1, per investigator assessment, ●Change from baseline in health economics and outcomes research / patient-reported outcomes (HEOR/PRO) parameters, ●Serum concentration and PK parameters for zanidatamab, ●Serum concentrations for tislelizumab—

Countries

Belgium, Estonia, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026