NCT07537010 3D1015 Injection for Patients With mCRPC
| NCT ID | NCT07537010 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chunjing Yu |
| Condition | Metastatic Castration-resistant Prostate Cancer, mCRPC |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2025-08-27 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits. 2. Male, aged 18 years or older. 3. Histologically or cytologically confirmed prostate adenocarcinoma. 4. Castrate levels of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). 5. Must be 68Ga-PSMA PET/CT scan positive. 6. ECOG performance status of 0 to 2. 7. Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments. 8. Presence of at least one metastatic lesion at baseline. 9. Adequate Organ Function. 10. Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia). Exclusion Criteria: 1. Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry. 2. Life expectancy of \< 6 months, as assessed by the investigator. 3. A superscan as seen in the baseline bone scan. 4. Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments. 5. Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds. 6. Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07537010 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-resistant Prostate Cancer, mCRPC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07537010 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07537010 currently recruiting?
Yes, NCT07537010 is actively recruiting participants. Contact the research team at ycjwxd1978@jiangnan.edu.cn for enrollment information.
Where is the NCT07537010 trial being conducted?
This trial is being conducted at Wuxi, China.
Who is sponsoring the NCT07537010 clinical trial?
NCT07537010 is sponsored by Chunjing Yu. The trial plans to enroll 8 participants.
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