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RC-48 Combined With GLS-010 in HER2-overexpressed Patients With Previously Treated Unresectable Biliary Tract Cancer

NCT05540483 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-09-16

No results posted yet for this study

Summary

This is a multicenter, single-arm, open-labal, phase II clinical study with a planned enrollment of 31 patients with HER2-overexpressing unresectable locally advanced or metastatic biliary carcinoma who had failed previous treatment. The efficacy and safety of the study were evaluated according to RECIST V1.1.

Conditions

  • Biliary Carcinoma

Interventions

DRUG

Disitamab Vedotin combined with Zimberelizumab

Treatment regimen: Disitamab Vedotin , 2.5mg/kg, intravenously D1, once every 14 days (Q2W), combined with Zimberelizumab, 240mg, intravenously D1, once every 14 days (Q2W).

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Overall Study Officials Xiaofeng · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-08-01
Completion
2025-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540483 on ClinicalTrials.gov