Trial · NCT04466891
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
NCT04466891, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2024-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers. Trials, record NCT04466891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04466891
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
- NCT number
- NCT04466891
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- HER2-amplified Biliary Tract Cancers
- Interventions
- ZW25 (Zanidatamab)
- First posted
- 2020-07-10
- Last updated
- 2025-09-15
- Other registries' IDs
- eudract:2020-000459-11
- Results first posted
- 2024-08-21
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Up to 34 months | Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions. |
| Secondary | Duration of Response (DOR) by ICR | Up to 45 months | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause |
| Secondary | DOR ≥ 16 Weeks by ICR | 24 weeks, up to 45 months | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 |
| Secondary | Disease Control Rate (DCR) by ICR | Up to 45 months | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 |
| Secondary | Progression-free Survival (PFS) by ICR | Up to 45 months | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause |
| Secondary | ORR by Investigator Assessment | Up to 45 months | Number of subjects who achieved a confirmed BOR of either CR or PR during treatment per RECIST 1.1 |
| Secondary | DOR by Investigator Assessment | Up to 45 months | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause |
| Secondary | DOR ≥ 16 Weeks by Investigator Assessment | 24 weeks, up to 45 months | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 |
| Secondary | DCR by Investigator Assessment | Up to 45 months | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 |
| Secondary | PFS by Investigator Assessment | Up to 45 months | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Up to 34 months | Assessed in participants with available data in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) by ICR | Up to 45 months | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)), as evaluated by ICR, were evaluated for this outcome. | months | MEDIAN |
| SECONDARY | DOR ≥ 16 Weeks by ICR | 24 weeks, up to 45 months | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)), as evaluated by ICR, were evaluated for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) by ICR | Up to 45 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) by ICR | Up to 45 months | months | MEDIAN | |
| SECONDARY | ORR by Investigator Assessment | Up to 45 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | DOR by Investigator Assessment | Up to 45 months | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)) as per investigator assessment, were evaluated for this outcome. | months | MEDIAN |
| SECONDARY | DOR ≥ 16 Weeks by Investigator Assessment | 24 weeks, up to 45 months | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)) as per investigator assessment, were evaluated for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DCR by Investigator Assessment | Up to 45 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PFS by Investigator Assessment | Up to 45 months | months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Cohort I | 33 | Participants | ||
| Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Cohort II | 0 | Participants | ||
| Duration of Response (DOR) by ICR | Cohort I | 14.92 | 95% Confidence Interval 7.39 to 23.98 | months | |
| DOR ≥ 16 Weeks by ICR | Cohort I | 28 | Participants | ||
| Disease Control Rate (DCR) by ICR | Cohort I | 55 | Participants | ||
| Disease Control Rate (DCR) by ICR | Cohort II | 3 | Participants | ||
| Progression-free Survival (PFS) by ICR | Cohort I | 5.49 | 95% Confidence Interval 3.65 to 7.29 | months | |
| Progression-free Survival (PFS) by ICR | Cohort II | 1.87 | 95% Confidence Interval 1.22 to NA | months | |
| ORR by Investigator Assessment | Cohort I | 34 | Participants | ||
| ORR by Investigator Assessment | Cohort II | 0 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort I | 80 | |
| Overall Study | STARTED | Cohort II | 7 | |
| Overall Study | COMPLETED | Cohort I | 0 | |
| Overall Study | COMPLETED | Cohort II | 0 | |
| Overall Study | NOT COMPLETED | Cohort I | 80 | |
| Overall Study | NOT COMPLETED | Cohort II | 7 |
Source ClinicalTrials.gov
Adverse events218
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort I | 18 | 80 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort II | 3 | 7 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort I | 0 | 80 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort II | 1 | 7 | |
| other | Palpitations | Cardiac disorders | Cohort I | 0 | 80 | |
| other | Palpitations | Cardiac disorders | Cohort II | 1 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort I | 16 | 80 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort II | 0 | 7 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort I | 7 | 80 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort II | 0 | 7 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort I | 60 | 80 |
| Total, all-cause mortality | Cohort II | 6 | 7 |
| Total, other adverse events | Cohort I | 78 | 80 |
| Total, other adverse events | Cohort II | 5 | 7 |
| Total, serious adverse events | Cohort I | 43 | 80 |
| Total, serious adverse events | Cohort II | 3 | 7 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort I vs Cohort II: ORR by Investigator Assessment | Trial comparisons |
| Cohort I vs Cohort II: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Trial comparisons |
| Cohort I vs Cohort II: DCR by Investigator Assessment | Trial comparisons |
| Cohort I vs Cohort II: Incidence of Laboratory Abnormalities | Trial comparisons |
| Cohort I vs Cohort II: Incidence of Anti-drug Antibodies (ADAs) | Trial comparisons |
| Cohort I vs Cohort II: deaths from any cause | Trial comparisons |
| Cohort I vs Cohort II: Disease Control Rate (DCR) by ICR | Trial comparisons |
| Cohort I vs Cohort II: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04466891
GET https://conductscience.org/api/trials/v1/NCT04466891/results?page=2