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RECRUITING Phase 3

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

NCT06467357 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

Conditions Studied

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG Trastuzumab deruxtecan
  • DRUG Rilvegostomig
  • DRUG Durvalumab

Study Locations (20)

California

  • Research Site — Fullerton
  • Research Site — La Jolla
  • Research Site — Los Alamitos
  • Research Site — Los Angeles
  • Research Site — Los Angeles
  • Research Site — San Francisco

Florida

  • Research Site — Fort Myers
  • Research Site — Jacksonville
  • Research Site — St. Petersburg
  • Research Site — Tampa
  • Research Site — West Palm Beach

Arizona

  • Research Site — Scottsdale
  • Research Site — Tucson
  • Research Site — Tucson

Illinois

  • Research Site — Chicago
  • Research Site — Niles

Georgia

  • Research Site — Atlanta

Idaho

  • Research Site — Coeur d'Alene

Maryland

  • Research Site — Towson

Massachusetts

  • Research Site — Worcester

Trial Details

FieldValue
Enrollment Target 620 participants
Start Date 2024-08-12
Est. Completion 2029-05-16
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06467357

The ClinicalTrials.gov registry entry for NCT06467357 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 620 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 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 Cisplatin 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: NCT06467357 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT06467357 about?

NCT06467357 is a clinical study titled "Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer". The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

What is the current status of trial NCT06467357?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 620 participants. The study started on 2024-08-12. Estimated completion is 2029-05-16.

What conditions does trial NCT06467357 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 NCT06467357?

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

Who is sponsoring clinical trial NCT06467357?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06467357 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Idaho. 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