Trial intelligence / Profile preview

HERBOT: Trastuzumab + Nivolumab + Chemo in HER2+ BTC

NCT05749900Phase 2

Key facts

Status: Recruiting
Start: May 2023
Primary completion: Feb 2026
Countries: 1
Sponsor: Yonsei University
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: trastuzumab
Conditions: biliary tract cancer (BTC)

Overview

Phase 2, open-label, single-arm trial of trastuzumab in biliary tract cancer (BTC), sponsored by Yonsei University. Primary endpoints: Recommended Phase II Dose up to 4 years and Objective Response Rate up to 4 years. Started May 2023; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

Trastuzumab+Nivolumab+Gemcitabine+Cisplatin
Trastuzumab + Nivolumab + Gemcitabine + Cisplatin

Who it enrols

Patients with HER2-positive advanced biliary tract cancer, ECOG 0-1, and no prior systemic therapy for advanced disease (except adjuvant >6 months prior).

Endpoints

Primary

Recommended Phase II Doseup to 4 years
Objective Response Rateup to 4 years

Secondary

Progression Free Survivalup to 4 years
Overall Survivalup to 4 years
Disease Control Rateup to 4 years
Duration of Responseup to 4 years
Treatment-related adverse eventsup to 4 years
Quality of Lifeup to 4 years

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