A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
NCT03809013 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2023-11-27
Summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with HER2 overexpressing locally advanced or metastatic urothelial cancer.
Conditions
Interventions
- DRUG
-
RC48-ADC
2.0mg/kg IV every 2 weeks
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jun Guo, Ph.D · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-07
- Primary Completion
- 2021-03-04
- Completion
- 2023-06-05
Countries
- China
Study Locations
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