Last updated 16 days ago
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
286 patients around the world
Available in Puerto Rico, Argentina, United States
Jazz Pharmaceuticals
3Research sites
286Patients around the world
This study is for people with
Bile Duct Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 with gemcitabine and a platinum agent 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.
- 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.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Fundación Ars Médica - San Salvador de Jujuy
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
StudyJZP598-302
SponsorJazz Pharmaceuticals
Conditions
Bile Duct Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06282575
