🏛️ Verified NIH Record • Updated 2026-07-13

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer (NCT06282575)

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

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Jazz Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (14 items).

Location: City of Hope(City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (185 Sites)

Showing the first 25 of 185 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
  • Norton Cancer Institute - Audubon — Louisville, Kentucky
  • Ochsner Clinic Foundation — New Orleans, Louisiana
  • Tufts Medical Center — Boston, Massachusetts
  • University of Michigan Hospital — Ann Arbor, Michigan
  • Henry Ford Health System — Detroit, Michigan
  • Minnesota Oncology Hematology, P.A. — Maple Grove, Minnesota
  • Atlantic Health System/Morristown Medical Center — Morristown, New Jersey
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center — New York, New York
  • Memorial Sloan Kettering Cancer Centers — New York, New York
  • Oregon Health and Science University — Portland, Oregon
  • Saint Francis Cancer Center — Greenville, South Carolina
  • SCRI Oncology Partners — Nashville, Tennessee
  • Texas Oncology - DFW — Dallas, Texas
  • University of Texas Southwestern Medical Center — Dallas, Texas
  • The Univerrsity of Texas MD Anderson Cancer Center — Houston, Texas
  • Virginia Commonwealth University, VCU Health — Richmond, Virginia
  • Hospital Italiano de Buenos Aires — Ciudad Autónoma de Buenos Aires (caba), Buenos Altes
  • Fundación ARS Médica — San Salvador de Jujuy, Jujuy Province
  • Centro de Investigaciónes Clínicas - Clínica Viedma — Viedma, Río Negro Province
  • Hospital Provincial Del Centenario — Rosario, Santa Fe Province

📞 Contact the Study Coordinator

Phone: (215) 832-3750

Email: ClinicalTrialDisclosure@JazzPharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Biliary Tract Cancer

Explore by condition: All Biliary Tract Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗