OncoMatch/Clinical Trials/NCT06282575
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Is NCT06282575 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for biliary tract cancer.
Treatment: Zanidatamab · Cisplatin · Gemcitabine · Pembrolizumab · Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
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
Required: HER2 (ERBB2) overexpression and amplification (IHC 2+ and ISH+)
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (cisplatin, gemcitabine) — advanced unresectable or metastatic disease
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.
Cannot have received: HER2-targeted therapy
Prior treatment with a HER2-targeted agent
Cannot have received: checkpoint inhibitor
Exception: durvalumab or pembrolizumab allowed
Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope(City of Hope National Medical Center, City of Hope Medical Center) · Duarte, California
- Rocky Mountain Cancer Centers, LLP · Lone Tree, Colorado
- AdventHealth Hematology and Oncology · Orlando, Florida
- Winship Cancer Institute · Atlanta, Georgia
- The University of Kansas Cancer Center - Westwood · Westwood, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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