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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration-resistant Prostate Cancer, mCRPC
• Intervention / Treatment: Drug: Lu 177-PSMA-3D1015 Injection

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: chunjing Yu; Phone Number: 15312238622; Email: ycjwxd1978@jiangnan.edu.cn

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Recruiting
      • Jiangnan University Affiliated Hospital
      • Contact: chunjing Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu 177-PSMA-3D1015	Drug: Lu 177-PSMA-3D1015 Injection; 3D1015 is administered intravenously at an individualized dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)	Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs.	From first dose of study drug through end of treatment (~36-48 weeks)
Occurrence of Dose-Limiting Toxicities (DLTs)	Number of participants experiencing dose-limiting toxicities (DLTs) .	From first dose of study drug through end of treatment (~36-48 weeks)
Absorbed Dose	Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data.	From first dose of study drug through end of treatment (~36-48 weeks)
Effective Half-Life	Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging.	From first dose of study drug through end of treatment (~36-48 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with a PSA change from baseline	The effect of Lu 177-PSMA-3D1015 on prostate-specific antigen (PSA) kinetics.	From first dose of study drug through end of treatment (~36-48 weeks)
Objective Response Rate (ORR)	Percentage of participants with a complete response (CR) or partial response (PR).	From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)
Radiographic progression-free survival (rPFS)	rPFS per investigator assessment.	From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)

Collaborators and Investigators

• Sponsor: Chunjing Yu

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 3D1015-CN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No