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Tests treatment safety and results for Biliary Tract Cancer
Official title Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06282575
What this study is testing
What is Zanidatamab?
Zanidatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancer.
Also referred to as ZW25, JZP598.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or...
- 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...
- 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...
- Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per...
You likely can't join if
- 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...
- Use of systemic corticosteroids.
- Brain metastases
- Severe chronic or active infections
See the full eligibility 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...
- 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...
- 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.
- Use of phenytoin
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Lone Tree, Colorado, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Maple Grove, Minnesota, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Portland, Oregon, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Ciudad Autónoma de Buenos Aires (caba), Buenos Altes, Argentina
+ 140 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Lone Tree, Colorado, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Westwood, Kansas, United States; Louisville, Kentucky, United States and 154 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.