Actively Recruiting
3D1015 Injection for Patients With mCRPC
Led by Chunjing Yu · Updated on 2026-04-17
8
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.
CONDITIONS
Official Title
3D1015 Injection for Patients With mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of understanding and providing written informed consent and willing to follow all study treatments and visits
- Male, aged 18 years or older
- Histologically or cytologically confirmed prostate adenocarcinoma
- Castrate serum/plasma testosterone levels (< 50 ng/dL or < 1.7 nmol/L)
- Positive 68Ga-PSMA PET/CT scan
- ECOG performance status of 0 to 2
- Confirmed progressive metastatic castration-resistant prostate cancer refractory to or progressed after prior treatments
- At least one metastatic lesion present at baseline
- Adequate organ function
- Prior treatment-related toxicities resolved to Grade ≤ 2 (except alopecia)
You will not qualify if you...
- Received other systemic anti-cancer therapies within 4 weeks before study entry
- Life expectancy less than 6 months as judged by the investigator
- Baseline bone scan showing a superscan
- Clinically significant, uncontrolled, or unstable medical conditions that risk patient safety or study assessments
- Known hypersensitivity or severe intolerance to the study drug or related compounds
- Any medical, psychiatric, or logistical condition that would prevent following the study protocol or endanger safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, China
Actively Recruiting
Research Team
C
chunjing Yu
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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