A Phase 2 interventional study of Disitamab Vedotin（RC48-ADC） in Metastatic Castration-resistant Prostate Cancer, sponsored by Peking University Cancer Hospital & Institute. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
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.
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. Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death. During the treatment, participants will evaluate every 4 weeks, including PSA testing every 4 weeks and tumor evaluation according to PCWG3 standards every 8 weeks. If the patient develops disease progression, the treatment will be discontinued and survival follow-up will be conducted every 8 weeks.
Peking University Cancer Hospital & Institute is the lead sponsor of 267 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Disitamab Vedotin(RC48-ADC) :2.0mg/kg，Q2W
Drug: Disitamab Vedotin（RC48-ADC）
Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death.
Also known as: RC48
PSA response rate
The proportion of subjects receiving at least one cycle of treatment with the study drug who had at least a 50% reduction in PSA from baseline and maintained it for more than 21 days (PSA50).
Time frame: 24 months
ORR，Objective Response Rate
The proportion of patients who achieved patial response and complete reponse.
Time frame: 24 months
Overall survival (OS)
median OS or OS rate
Time frame: From the first dose to death from any cause，up to two years.
Progression free survival
median PFS or PFS rate
Time frame: From the first dose to the first documentation of disease progression or death, up to two years.
No study locations are listed for this record.
Plan to share: Yes — Article publication
Supporting information: Study protocol
Time frame: Determine after article publication
Access criteria: Determine after article publication
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: RC48
Peking University Cancer Hospital & Institute →