Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Jazz Pharmaceuticals (Voir sur ClinicalTrials)
juillet 2024
avril 2030
02 avril 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 17/04/2026 08:05:35 | Contacter | ||
Critères
Tous
Inclusion Criteria
1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including
Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic
Cholangiocarcinoma (ECC).
2. Locally advanced unresectable or metastatic BTC and not eligible for curative
resection, transplantation, or ablative therapies.
3. 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.
4. 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.
5. Assessable (measurable or non-measurable) disease as defined by Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
6. Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific
regulations).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Adequate organ function
9. Females of childbearing potential must have a negative pregnancy test result.
10. Females of childbearing potential and males with a partner of childbearing potential
must be willing to use 2 methods of birth control.
Exclusion Criteria
1. Prior treatment with a HER2-targeted agent
2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
3. 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.
4. Use of systemic corticosteroids.
5. Brain metastases
6. Severe chronic or active infections
7. History of allogeneic organ transplantation.
8. Active or prior autoimmune inflammatory conditions
9. History of interstitial lung disease or non-infectious pneumonitis.
10. Participation in another clinical trial with an investigational medicinal product
within the last 3 months.
11. Females who are breastfeeding
12. Any other medical, social, or psychosocial factors that, in the opinion of the
investigator, could impact safety or compliance with study procedures.
13. Use of phenytoin
1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including
Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic
Cholangiocarcinoma (ECC).
2. Locally advanced unresectable or metastatic BTC and not eligible for curative
resection, transplantation, or ablative therapies.
3. 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.
4. 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.
5. Assessable (measurable or non-measurable) disease as defined by Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
6. Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific
regulations).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Adequate organ function
9. Females of childbearing potential must have a negative pregnancy test result.
10. Females of childbearing potential and males with a partner of childbearing potential
must be willing to use 2 methods of birth control.
Exclusion Criteria
1. Prior treatment with a HER2-targeted agent
2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
3. 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.
4. Use of systemic corticosteroids.
5. Brain metastases
6. Severe chronic or active infections
7. History of allogeneic organ transplantation.
8. Active or prior autoimmune inflammatory conditions
9. History of interstitial lung disease or non-infectious pneumonitis.
10. Participation in another clinical trial with an investigational medicinal product
within the last 3 months.
11. Females who are breastfeeding
12. Any other medical, social, or psychosocial factors that, in the opinion of the
investigator, could impact safety or compliance with study procedures.
13. Use of phenytoin