Lu‑177 PSMA‑3D1015 injections for men with metastatic castration‑resistant prostate cancer

Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study

This trial will test Lu‑177 PSMA‑3D1015 injections in adult men with PSMA‑positive metastatic castration‑resistant prostate cancer to see if the treatment is safe and shows anti-tumor activity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Affiliated Hospital of Jiangnan University (Academic / other)
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT07537010 on ClinicalTrials.gov

What this trial studies

This open‑label Phase 1 trial gives intravenous Lu‑177 PSMA‑3D1015 with dosing individualized per participant to optimize safety and exposure. The main goals are to measure safety, tolerability, and radiation dosimetry of the agent, while secondary objectives look for preliminary anti‑tumor activity and help define an optimal dosing regimen. Eligible participants are adult men with histologically confirmed mCRPC, castrate‑level testosterone, PSMA‑positive disease on 68Ga‑PSMA PET/CT, and adequate organ function after prior treatments. Treatment and follow‑up visits are performed at a single center with imaging and lab monitoring to track toxicity and response.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 or older with histologically confirmed PSMA‑positive mCRPC, castrate testosterone levels, ECOG 0–2, at least one metastatic lesion, adequate organ function, and disease that has progressed after prior therapies.

Not a fit: Patients with PSMA‑negative scans, a superscan on bone imaging, life expectancy under six months, recent systemic anti‑cancer therapy, or inadequate organ function are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this targeted radioligand could shrink tumors and prolong disease control with a manageable safety profile.

How similar studies have performed: PSMA‑targeted radioligand therapies such as Lu‑177‑PSMA‑617 have demonstrated clinical benefit in mCRPC, so the general approach has precedent even though 3D1015 is a novel compound.

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.

Where this trial is running

Wuxi, Jiangsu

• Jiangnan University Affiliated Hospital — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: chunjing Yu

Conditions Metastatic Castration-resistant Prostate Cancer, mCRPC