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

Browse trials for

• Breast Neoplasms 12,547
• Stomach Neoplasms 2,851
• Esophageal Neoplasms 1,593
• Colorectal Neoplasms 5,600
• Endometrial Neoplasms 1,325
• Carcinoma, Non-Small-Cell Lung 6,491

Keywords

• JZP598
• ZW25
• HER2 IHC 3+ Overexpression Solid Tumors

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Study arms

• Experimental
  Zanidatamab treatment arm

  Eligible participants receiving zanidatamab treatment

  Drug: Zanidatamab

Interventions

• DrugZanidatamab

  Administered by intravenous (IV) infusion

  Also known as: ZW25, JZP598, ZIIHERA®

Primary outcomes

1. 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)

   Time frame: Up to 2.5 years

Secondary outcomes

1. 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.

   Time frame: Up to 2.5 years

2. 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)

   Time frame: Up to 2.5 years

3. 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.

   Time frame: Up to 2.5 years

4. 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.

   Time frame: Up to 2.5 years

5. 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.

   Time frame: Up to 2.5 years

6. 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

   Time frame: Up to 2.5 years

7. 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

   Time frame: Up to 2.5 years

8. 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.

   Time frame: Up to 2.5 years

9. 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.

   Time frame: Up to 2.5 years

10. Overall Survival (OS)

    OS is defined as the time in months from randomization to the date of death due to any cause.

    Time frame: Up to 3.5 years

11. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) As Graded by NCI CTCAE Version 5.0

    Time frame: Up to 2.5 years

12. Number of Participants With Dose Reductions

    Time frame: Up to 2.5 years

13. Number of Participants Discontinuing Study Treatment Due to TEAEs

    Time frame: Up to 2.5 years

14. Serum Concentrations of Zanidatamab

    Time frame: Up to 2.5 years

15. Number of Participants Positive for Anti-drug Antibodies to Zanidatamab

    Time frame: Up to 2.5 years

16. Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE)

    Time frame: Up to 2.5 years

17. Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library

    Time frame: Up to 2.5 years

18. Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)

    Time frame: Up to 2.5 years

19. 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)

    Time frame: Up to 2.5 years

Individual participant data

Plan to share: Yes — In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.