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An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer

NCT05356351 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-02

No results posted yet for this study

Summary

An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer.It's arm to evaluate the neoadjuvant treatment of Her2-positive Muscle-invasive Bladder Cancer in patients with objective response rate (ORR),Duration of response (DoR) , progression-free survival (PFS), overall survival (OS), and safety.

Conditions

  • Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance

Interventions

DRUG

RC48- ADC

RC48-ADC 2.0 mg/kg D1,Triplizumab 3mg/kg D2，Q2W

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Southwest Hospital, China

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Chongqing University Cancer Hospital

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Air Force Medicial University

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

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
2022-05-01
Primary Completion
2023-07-01
Completion
2027-07-30

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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 NCT05356351 on ClinicalTrials.gov