Phase 2
N=87
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
HER2-amplified Biliary Tract Cancers
Bottom Line
View on ClinicalTrials.gov: NCT04466891 ↗Enrolled (actual)
87
Serious AEs
52.9%
Results posted
Aug 2024
Primary outcome: Primary: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) — 33; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ZW25 (Zanidatamab) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) |
33; 0 | — |
| SECONDARY Duration of Response (DOR) by ICR |
14.92 | — |
| SECONDARY DOR ≥ 16 Weeks by ICR |
28 | — |
| SECONDARY Disease Control Rate (DCR) by ICR |
55; 3 | — |
| SECONDARY Progression-free Survival (PFS) by ICR |
5.49; 1.87 | — |
| SECONDARY ORR by Investigator Assessment |
34; 0 | — |
| SECONDARY DOR by Investigator Assessment |
11.10 | — |
| SECONDARY DOR ≥ 16 Weeks by Investigator Assessment |
31 | — |
| SECONDARY DCR by Investigator Assessment |
54; 1 | — |
| SECONDARY PFS by Investigator Assessment |
5.37; 1.77 | — |
| SECONDARY Overall Survival |
15.54; 5.52 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
78; 6; 61; 2; 43; 3 | — |
| SECONDARY Incidence of Laboratory Abnormalities |
37; 7 | — |
| SECONDARY Maximum Serum Concentration of ZW25 |
457.6; 443.6 | — |
| SECONDARY Trough Concentration of ZW25 |
73.4; 46.5 | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADAs) |
1; 0 | — |
Summary
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
Eligibility Criteria
Inclusion Criteria
- Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC.
- Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
- Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease, and experienced disease progression after or developed intolerance to the most recent prior therapy. For subjects who received gemcitabine in prior adjuvant or neoadjuvant treatment, if progression occurred 470 ms.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease.
- Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.
Data sourced from ClinicalTrials.gov (NCT04466891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.