Clinical trial · Interventional
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
NCT07101354CI-TRIAL-00093055DGPR1008completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate CA | — | UNRESOLVED | — |
| Prostate Cancer Patients Undergoing Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6) | Drug | — | UNRESOLVED |
| 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) | Drug | — | UNRESOLVED |
| 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6) | Drug | — | UNRESOLVED |
| 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6) | Drug | — | UNRESOLVED |
| Dose Group 0 (n=8) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)
- description
- On the day of administration, subjects will be randomized to receive the DGPR1008 Injection (0.01 mg/kg; n=6) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.
- interventionNames
- Drug: 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)
- type
- EXPERIMENTAL
- label
- 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)
- description
- On the day of administration, subjects will be randomized to receive the investigational product (0.02 mg/kg; n=6) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Provide signed informed consent prior to the trial, and fully understand the trial content, procedures, and potential adverse reactions. * Be able to complete the study as required by the trial protocol. * Be an adult male aged 18-65 years (inclusive). * Have a body weight ≥50 kg and a body mass index (BMI) of 18-30 kg/m² (calculated as BMI = weight \[kg\]/height² \[m²\]). * Neither the subject nor their partner/spouse plan to conceive or donate sperm from screening until 3 months after the trial completion, and agree to use effective non-pharmacological contraception during the study. Exclusion Criteria: Subjects will be excluded if any of the following apply: * Clinically significant abnormalities (physical exam, vital signs, ECG, labs) or severe medical history (cardiac, hepatic, renal, GI, neurological, respiratory, psychiatric, metabolic) deemed unsuitable by the investigator. * History of allergy (≥2 drugs/foods, milk/pollen), or allergy to investigational drug/components. * Alcohol abuse (\>14 units/week) in prior 3 months or positive breathalyzer. * Positive serology for HBsAg, anti-HCV, anti-HIV, or syphilis. * Positive urine drug screen, drug abuse history (past 5 years), or illicit drug use (past 3 months). * Blood loss \>400 mL or platelet donation (2 therapeutic units) in prior 3/1 months, respectively. * Smoking \>5 cigarettes/day (past 3 months) and inability to abstain. * Surgery within prior 3 months. * Participation in another clinical trial (investigational product) within prior 3 months. * Prescription medication use within prior 1 month. * OTC drugs, herbal supplements, or vitamins within prior 48 hours. * Other conditions deemed unsuitable by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.