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

StatusRecruiting
PhasePhase 2
Started2025-01-14
View on ClinicalTrials.gov ↗

Amendment history

2026-07-08
Study Status v18
Re-verified, no change to tracked fields
2026-06-05
Study Status, Contacts/Locations v17
Trial sites expanded: 21 → 28 locations
2026-04-06
9 amendments v8-v16
9 re-verifications since 2025-07-11, no change to tracked fields
2025-06-24
Study Status, Contacts/Locations v7
Study sites20→21
2025-05-29
Study Status, Contacts/Locations v6
Study sites18→20
Show 5 earlier versions
2025-05-05
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v5
Study sites14→18
Eligibility criteria+375 characters
[...] eruxtecan (T-DXd) is required. HER2 overexpression (IHC 3+) viamust Immunohistochemistrybe (IHC)determined by a sponsor designated central laboratory. All participants must have adequate tumor sample for submi [...] 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 < Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment > 7 days prior to Cycle 1 Day 1. Prior stereotactic radiosurgery or stereotactic radiotherapy [...] ays (≥ [...]
2025-03-18
2 amendments v3-v4
2 re-verifications since 2025-02-18, no change to tracked fields
2025-01-27
Study Status, Contacts/Locations v2
Start dateestimated 2024-12-31→confirmed 2025-01-14
Study sites2→14
2024-12-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2024-11-29→2024-12-31
Study sites1→2
2024-11-16
Original filing
Jazz Pharmaceuticals
34 trials monitored
See 1 trial at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
and 8 more diseases
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.
Trial Details
NCT Number NCT06695845
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Ireland Limited
Conditions Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer +4 more
Enrollment 200 participants
Start Date 2025-01-14
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-10