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Recruiting NCT07537010

3D1015 Injection for Patients With mCRPC

Phase I Interventional Metastatic Castration-resistant Prostate Cancer, mCRPC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lu 177-PSMA-3D1015 Injection.
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer, mCRPC. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Lu 177-PSMA-3D1015 Injection
    3D1015 is administered intravenously at an individualized dose.

Primary outcome measures

  • Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Time frame: From first dose of study drug through end of treatment (~36-48 weeks)]
  • Occurrence of Dose-Limiting Toxicities (DLTs) [Time frame: From first dose of study drug through end of treatment (~36-48 weeks)]
  • Absorbed Dose [Time frame: From first dose of study drug through end of treatment (~36-48 weeks)]
  • Effective Half-Life [Time frame: From first dose of study drug through end of treatment (~36-48 weeks)]
Secondary outcome measures (3)
  • The proportion of patients with a PSA change from baseline [Time frame: From first dose of study drug through end of treatment (~36-48 weeks)]
  • Objective Response Rate (ORR) [Time frame: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)]
  • Radiographic progression-free survival (rPFS) [Time frame: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Jiangnan University Affiliated Hospital — Wuxi

Identifiers

NCT: NCT07537010 · 3D1015-CN-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗