Actively Recruiting
A Phase II Study to Evaluate Disitamab Vedotin Safety and Effectiveness in Men With HER2-Positive Locally Advanced or Metastatic Castration-Resistant Prostate Cancer
Led by RemeGen Co., Ltd. · Updated on 2024-05-23
40
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Disitamab Vedotin to treat men with locally advanced or metastatic castration-resistant prostate cancer that shows HER2 expression. This phase II, multicenter study aims to evaluate the safety, effectiveness, and how the body processes this drug in patients who have already received androgen deprivation therapy and new hormone treatments. Participants will receive Disitamab Vedotin through an intravenous infusion at a dose of 2.0 mg per kilogram every two weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, the participant chooses to stop, or the study ends. The study will include 40 men with HER2-positive prostate cancer. During the study, participants will have regular assessments including imaging scans to track cancer progression, blood tests, and monitoring for side effects. Researchers will measure how long patients live without cancer growth visible on scans, response rates, time to specific progression markers, and overall survival. Safety evaluations will continue for up to about two years after starting treatment.
CONDITIONS
Brief Title
Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathology confirmed prostate adenocarcinoma
- Locally advanced or metastatic prostate cancer
- Prostate cancer progression during androgen deprivation therapy or bilateral orchiectomy
- Serum testosterone level less than or equal to 50 ng/dL before study drug
- Continuous androgen deprivation therapy or previous bilateral orchiectomy during study
- Confirmed HER2 expression or gene amplification/mutation
- Ability to provide tissue samples for HER2 testing
- Previous androgen deprivation and new hormone therapy with disease progression
- Adequate blood counts, liver and kidney function within 7 days before first dose
- Left ventricular ejection fraction 50% or higher
- ECOG Physical Status 0 or 1
- Expected survival of at least 6 months
- Agreement to use contraception if spouse of childbearing age
- Ability to understand and sign informed consent form
You will not qualify if you...
- Recent chemotherapy, hormone therapy, targeted therapy, immunotherapy, or other antitumor treatments within 5 half-lives or 2 weeks before study drug, except maintenance castration or bone therapy
- Active central nervous system metastases or carcinomatous meningitis
- Previous anti-HER2 therapy
- Major surgery or systemic radiotherapy within 4 weeks before study drug
- Toxicity from prior cancer therapy not recovered to grade 1 or below
- Known allergies to study drug components
- Other malignancies affecting life expectancy except certain skin or bladder cancers
- Severe infection within 14 days before study drug
- Positive tests for hepatitis B, hepatitis C, or HIV
- Serious cardiovascular disease or uncontrolled hypertension
- Peripheral neuropathy grade 2 or higher
- Unstable systemic diseases like diabetes, liver cirrhosis, pneumonitis, or lung disease
- Other conditions judged by investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive Disitamab Vedotin as an intravenous infusion every 2 weeks until disease progression, intolerable toxicity, withdrawal, death, or study termination.
Infusions every 2 weeks
Trial Site Locations
Total: 3 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
2
The Third Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 1000853
Not Yet Recruiting
3
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
J
Jianmin Fang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here