NCT07537010RecruitingPhase 1
3D1015 Injection for Patients With mCRPC
Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 27 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Chunjing Yu
- Diseases
- Prostate cancer
- NCT number
- NCT07537010
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 8
- From 27 Aug 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
- Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
Other illness
- Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
- Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.
Other
- Life expectancy of \< 6 months, as assessed by the investigator.
- A superscan as seen in the baseline bone scan.
Who the study is looking for
- Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
- 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).
- Must be 68Ga-PSMA PET/CT scan positive.
- ECOG performance status of 0 to 2.
- Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments.
- Presence of at least one metastatic lesion at baseline.
- Adequate Organ Function.
- Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangnan University Affiliated Hospital Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.