Actively Recruiting
Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study
Led by Chunjing Yu · Updated on 2026-04-17
8
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). This open-label clinical study aims to assess the safety, tolerability, and dosimetry of the injection while also exploring its preliminary anti-tumor effects and the best dosing strategy. The study is led by Chunjing Yu and focuses on patients with advanced prostate cancer who have shown progression despite prior treatments. Participants will receive intravenous infusions of the 3D1015 drug, with doses tailored individually to optimize safety and outcomes. The treatment period lasts approximately 36 to 48 weeks, during which the dose and schedule may be adjusted. This is a phase 1 study without placebo or control groups, focusing on detailed monitoring of treatment effects and side effects. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor the absorbed radiation dose, effective half-life of the drug, and any adverse events. Researchers will also track prostate-specific antigen (PSA) changes, tumor response rates, and progression-free survival for up to five years. Safety and treatment effects will be carefully recorded throughout treatment and follow-up periods, with total participation lasting several years for ongoing evaluation.
CONDITIONS
Brief 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 able to comply with study requirements
- Male aged 18 years or older
- Histologically or cytologically confirmed prostate adenocarcinoma
- Castrate levels of serum/plasma testosterone (< 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
- Presence of at least one metastatic lesion at baseline
- Adequate organ function
- Resolution of prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia)
You will not qualify if you...
- Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry
- Life expectancy less than 6 months as assessed by investigator
- Presence of a superscan on baseline bone scan
- Clinically significant, uncontrolled, or unstable concurrent medical conditions
- Known hypersensitivity or severe intolerance to the study drug or related compounds
- Any medical, psychiatric, or logistical condition that may interfere with study compliance or safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 36 to 48 weeks
Participants receive intravenous 3D1015 injections at individualized doses as part of their treatment for metastatic castration-resistant prostate cancer.
Duration - Up to approximately 5 years
Participants are monitored for efficacy and safety outcomes after treatment ends, for up to approximately 5 years.
Trial Site Locations
Total: 1 location
1
Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, China
Actively Recruiting
Research Team
C
chunjing Yu
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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