3D1015 Injection for Patients With mCRPC

NCT07537010 | Recruiting Phase 1 DMC

• 1 other identifier: 3D1015-CN-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Castration-resistant Prostate Cancer, mCRPC

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• The proportion of patients with a PSA change from baseline

  From first dose of study drug through end of treatment (~36-48 weeks)

• Objective Response Rate (ORR)

  From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)

• Radiographic progression-free survival (rPFS)

  From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)

Study Arms (1)

Lu 177-PSMA-3D1015

EXPERIMENTAL

Drug: Lu 177-PSMA-3D1015 Injection

Interventions

Lu 177-PSMA-3D1015 Injection DRUG

3D1015 is administered intravenously at an individualized dose.

Lu 177-PSMA-3D1015

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
• Life expectancy of \< 6 months, as assessed by the investigator.
• A superscan as seen in the baseline bone scan.
• Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
• 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.

Sponsors & Collaborators

• Chunjing Yu: lead

Study Sites (1)

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, China

RECRUITING

Central Study Contacts

chunjing Yu

CONTACT

15312238622; ycjwxd1978@jiangnan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: August 27, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)