Actively Recruiting
Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Led by RemeGen Co., Ltd. · Updated on 2024-05-23
40
Participants Needed
3
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
CONDITIONS
Official 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 based on PSA, soft tissue, or bone lesions
- Serum testosterone level 50 ng/dL or below before first study drug dose
- Continuous androgen deprivation therapy or previous bilateral orchiectomy during the study
- Confirmed HER2 expression (IHC 1+, 2+, or 3+), HER2 gene amplification, or mutation
- Ability to provide tissue samples for HER2 detection confirmed by central lab
- Previous androgen deprivation therapy and new hormone therapy with disease progression
- Adequate blood counts and organ function within 7 days before first dose
- ECOG Physical Status Score of 0 or 1
- Expected survival of 6 months or more
- Agreement to use contraception if spouse is of childbearing age during and 6 months after study
- Ability to understand and sign informed consent form
You will not qualify if you...
- Antitumor therapies (chemotherapy, novel hormone, targeted, immunotherapy) within 5 half-lives or 2 weeks before first study drug, except maintenance castration or bone metastasis therapy
- Known active central nervous system metastases or carcinomatous meningitis
- Prior anti-HER2 therapy
- Major surgery, systemic radiotherapy, or biologic therapy within 4 weeks before first study drug, or minor surgery/local radiotherapy within 1 week before enrollment
- Unresolved toxicity from prior antineoplastic therapy above Grade 1 except alopecia and stable lab abnormalities
- Known allergy to study treatment or its components
- Other malignancies affecting life expectancy or disease assessment except cured non-melanoma skin or superficial bladder cancer
- Severe or persistent infection within 14 days before starting study drug
- Positive tests for active hepatitis B, hepatitis C, or HIV
- Serious cardiovascular disease within past 3 months or uncontrolled conditions
- Grade 2 or higher peripheral neuropathy
- Other uncontrolled systemic diseases such as diabetes, liver cirrhosis, pneumonitis, or obstructive pulmonary disease
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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