2025-01-14
2026-12-31
2027-12-31
200
NCT06695845
Jazz Pharmaceuticals
Jazz Pharmaceuticals
INTERVENTIONAL
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-11-16 | N/A | 2025-03-18 |
2024-11-16 | N/A | 2025-03-20 |
2024-11-19 | N/A | 2025-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Zanidatamab treatment arm Eligible participants receiving zanidatamab treatment | DRUG: Zanidatamab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR | The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to 2.5 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR | ICR assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause. | Up to 2.5 years |
| cORR by RECIST Version 1.1, as assessed by Investigator | Investigator assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to 2.5 years |
| Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator | Investigator assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause. | Up to 2.5 years |
| Time to Response (TTR), as assessed by ICR | ICR assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1. | Up to 2.5 years |
| Time to Response (TTR), as assessed by Investigator | Investigator assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1. | Up to 2.5 years |
| Disease control rate (DCR), as assessed by ICR | ICR assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria | Up to 2.5 years |
| Disease control rate (DCR), as assessed by Investigator | Investigator assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria | Up to 2.5 years |
| Progression Free Survival (PFS), as assessed by ICR | PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by ICR according to RECIST v1.1) or death from any cause, whichever occurs first. | Up to 2.5 years |
| Progression Free Survival (PFS), as assessed by Investigator | PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by Investigator according to RECIST v1.1) or death from any cause, whichever occurs first. | Up to 2.5 years |
| Overall Survival (OS) | OS is defined as the time in months from randomization to the date of death due to any cause. | Up to 3.5 years |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) As Graded by NCI CTCAE Version 5.0 | Up to 2.5 years | |
| Number of Participants With Dose Reductions | Up to 2.5 years | |
| Number of Participants Discontinuing Study Treatment Due to TEAEs | Up to 2.5 years | |
| Serum Concentrations of Zanidatamab | Up to 2.5 years | |
| Number of Participants Positive for Anti-drug Antibodies to Zanidatamab | Up to 2.5 years | |
| Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE) | Up to 2.5 years | |
| Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library | Up to 2.5 years | |
| Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5) | Up to 2.5 years | |
| Percentage of time when participants on treatment reported a high side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5) | Up to 2.5 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Clinical Trial Disclosure & Transparency Phone Number: 215-832-3750 Email: ClinicalTrialDisclosure@JazzPharma.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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