Actively Recruiting
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-07-30
20
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
N
Nanjing University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.
CONDITIONS
Official Title
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- Male patients aged 18 years or older
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+, or 3+)
- Documented castration-resistant prostate cancer with serum testosterone <1.73 nmol/L
- Evidence of metastatic disease by bone scan and/or CT/MRI
- Adequate organ function including specified blood counts, liver and kidney function, and heart function
- Use of medically acceptable contraception if partners are of child-bearing potential
You will not qualify if you...
- Known allergy to disitamab vedotin or abiraterone
- Other malignancies within 3 years except early-stage cured cancers
- Central nervous system metastases or carcinomatous meningitis, except stable treated brain metastases
- Poorly controlled or draining pericardial, pleural, peritoneal, or pelvic effusions
- Major surgery within 4 weeks before first dose or incomplete recovery
- Prior PSMA-targeted therapy
- Recent chemotherapy, radiotherapy, endocrine therapy, targeted therapy, immunotherapy, or other trial participation within specified washout periods
- Use of PSA-lowering herbal agents or systemic corticosteroids recently or planned during study
- Recent use of antineoplastic traditional Chinese medicine or blood products
- Unresolved toxicities from prior therapy above specified grades
- Active infections including HIV, hepatitis B or C, or untreated syphilis
- Severe heart conditions, uncontrolled arrhythmia, or risk of QT prolongation
- Recent serious vascular events
- Tumor invasion of major arteries with high bleeding risk
- Severe lung disease or recent significant hemoptysis
- Active gastrointestinal ulcers, perforation, fistula, or recent significant GI bleeding
- Uncontrolled concurrent diseases above grade 2
- Severe peripheral neuropathy, epilepsy, psychiatric disorders, substance or alcohol abuse
- Autoimmune disease, immunodeficiency, or organ transplantation
- Other conditions or laboratory abnormalities that may interfere with participation or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu 210000
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
H
Hongqian Guo Hong qian Guo
CONTACT
S
Shun Zhang Shun Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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