NCT06282575|RecruitingPhase 3FDA Drug

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

Jazz Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

JZP598-3022023-508219-21-00

Study Type

interventional

Target

286

Locations

24 countries

Sites

181

Timeline

RegisteredFeb 2024

StartedJul 2024

CompletionApr 2030

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

286

participants targeted

Target at P50-P75 for phase_3

Timeline

47mo left

Started Jul 2024

Longer than P75 for phase_3

Geographic Reach

24 countries

181 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

Study Progress32%

Jul 2024Apr 2030

First Submitted

Initial submission to the registry

February 21, 2024

Completed

7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed

5 months until next milestone

Study Start

First participant enrolled

July 19, 2024

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

February 21, 2024

Last Update Submit

March 23, 2026

Conditions

Biliary Tract Cancer

Keywords

JZP598ZW25HER-2 positive BIliary Tract cancerGallbladder CancerIntrahepatic Cholangiocarcinoma (ICC)Extrahepatic Cholangiocarcinoma (ECC)ZanidatamabHER-2 overexpressionHER-2 amplification

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors
PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
Up to 52 months

Secondary Outcomes (12)

Overall survival (OS) in participants with IHC 3+ tumors
Up to 68 months
Progression Free Survival for all participants
Up to 68 months
OS for all participants
Up to 68 months
Number of participants achieving Confirmed objective response rate (cORR)
Up to 68 months
Duration of response (DOR)
Up to 68 months
+7 more secondary outcomes

Study Arms (2)

Zanidatamab with Standard-of-care Therapy Arm

EXPERIMENTAL

Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Drug: ZanidatamabDrug: CisplatinDrug: GemcitabineDrug: PembrolizumabDrug: Durvalumab

Standard-of-care Therapy Arm

ACTIVE COMPARATOR

Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Drug: CisplatinDrug: GemcitabineDrug: PembrolizumabDrug: Durvalumab