Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT05955209 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-07-21
Summary
This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study.
Conditions
Interventions
- DRUG
-
Disitamab Vedotin(RC48-ADC)
Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death.
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
lead OTHER
Principal Investigators
-
Shuo Wang, Doctor · 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
- 2023-08-01
- Primary Completion
- 2024-08-01
- Completion
- 2025-08-01
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