Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT06282575 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG Zanidatamab
  • DRUG Durvalumab

Study Locations (20)

Texas

  • Texas Oncology - DFW — Dallas
  • University of Texas Southwestern Medical Center — Dallas
  • The Univerrsity of Texas MD Anderson Cancer Center — Houston

Michigan

  • University of Michigan Hospital — Ann Arbor
  • Henry Ford Health System — Detroit

New York

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center — New York
  • Memorial Sloan Kettering Cancer Centers — New York

California

  • City of Hope(City of Hope National Medical Center, City of Hope Medical Center) — Duarte

Colorado

  • Rocky Mountain Cancer Centers, LLP — Lone Tree

Florida

  • AdventHealth Hematology and Oncology — Orlando

Georgia

  • Winship Cancer Institute — Atlanta

Kansas

  • The University of Kansas Cancer Center - Westwood — Westwood

Trial Details

FieldValue
Enrollment Target 286 participants
Start Date 2024-07-19
Est. Completion 2030-04-01
Phase Phase 3

Sponsor

Jazz Pharmaceuticals

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06282575

The ClinicalTrials.gov registry entry for NCT06282575 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Biliary Tract Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06282575 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Texas, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06282575 about?

NCT06282575 is a clinical study titled "Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer". 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 regu...

What is the current status of trial NCT06282575?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2024-07-19. Estimated completion is 2030-04-01.

What conditions does trial NCT06282575 study?

This clinical trial studies the following conditions: Biliary Tract Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06282575?

The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Zanidatamab (DRUG), Durvalumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06282575?

This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06282575 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial