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Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC) - Trial NCT05955209

Access comprehensive clinical trial information for NCT05955209 through Pure Global AI's free database. This Phase 2 trial is sponsored by Peking University Cancer Hospital & Institute and is currently Not yet recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 40 participants.

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NCT05955209
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05955209
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Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)
An Open, Single Arm, Single Center Phase II Clinical Study Evaluating the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC) Progression After Novel Endocrine Therapy

Study Focus

Disitamab Vedotin๏ผˆRC48-ADC๏ผ‰

Interventional

drug

Sponsor & Location

Peking University Cancer Hospital & Institute

Timeline & Enrollment

Phase 2

Aug 01, 2023

Aug 01, 2025

40 participants

Primary Outcome

PSA response rate

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.

ICD-10 Classifications

Malignant neoplasm of prostate
Hyperplasia of prostate
Carcinoma in situ: Prostate
Special screening examination for neoplasm of prostate
Dysplasia of prostate

Data Source

ClinicalTrials.gov

NCT05955209

Non-Device Trial