Clinical Trials List
2024-06-11 - 2030-12-31
Phase III
Not yet recruiting2
Recruiting3
ICD-10C23
Malignant neoplasm of gallbladder
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9156.0
Malignant neoplasm of gallbladder
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
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ying-Chun Shen 無
- 黃信端 無
- 陳柏邑 無
- 林宗哲 無
- 莊建淮 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wan-Long Chuang 無
- Chia-Yen Dai 無
- 梁博程 無
- Ming-Lun Yeh 無
- Ming-Lung Yu 無
- 張庭遠 無
- Chung-Feng Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tai-Jan Chiu 無
- 黃詩喻 無
- 林昶廷 無
- 陳彥豪 無
- Yu-Li Su 無
- 吳佳哲 無
- 郭明濬 無
- 劉建廷 無
- Shau-Hsuan Li 無
- 歐信佑 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 余紹銘 無
- Hung-Chih Hsu 無
- Po-Jung Su 無
- Ming-Mo Hou 無
- 黃文冠 無
- Wen-Chi Shen 無
- Yung-Chia Kao 無
- Wen-Chi Chou 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
1013007200
1012002100
1010000610
1013005400
Dosage Form
Dosage
Endpoints
Inclution Criteria
Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function
Females of childbearing potential must have a negative pregnancy test result.
Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion Criteria
Prior treatment with a HER2-targeted agent
Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
Use of systemic corticosteroids.
Brain metastases
Severe chronic or active infections
History of allogeneic organ transplantation.
Active or prior autoimmune inflammatory conditions
History of interstitial lung disease or non-infectious pneumonitis.
Participation in another clinical trial with an investigational medicinal product within the last 3 months.
Females who are breastfeeding
Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
Use of phenytoin
The Estimated Number of Participants
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Taiwan
10 participants
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Global
286 participants
