NCT07101354

Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents

A Phase I/Ⅱa, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Haitao Niu, MD · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase I: Primary Research Objective: Evaluate the safety, tolerability, and pharmacokinetic characteristics of a single dose of DGPR1008 in healthy subjects. Secondary Research Objective: Based on the safety and pharmacokinetic results, assess the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of DGPR1008.

Conditions

• Prostate Cancer Patients Undergoing Radical Prostatectomy
• Prostate CA

Interventions

Type	Name	Description
DRUG	0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)	Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.
DRUG	0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)	Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.
DRUG	0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)	Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.
DRUG	0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6)	Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.
DRUG	Dose Group 0 (n=8)	Within the specified time frame, dose escalation will be conducted. Intravenous infusions will be administered according to randomization, with subjects receiving either the corresponding dose or placebo.

Timeline

• Start date: 2024-06-24
• Primary completion: 2024-07-29
• Completion: 2024-09-24
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: China