Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents (DGPR1008)

Haitao Niu, MD

Status and phase: Completed; Phase 1

Conditions: Prostate CA; Prostate Cancer Patients Undergoing Radical Prostatectomy

Treatments: Drug: 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6); Drug: 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6); Drug: Dose Group 0 (n=8); Drug: 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6); Drug: 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)

Study type: Interventional

Funder types: Other

Identifiers

NCT07101354

CXHL2400243 (Other Identifier)

QYFYEC2024-047-01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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32 participants in 5 patient groups, including a placebo group

0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)

Experimental group

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.

Treatment:

Drug: 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)

0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)

Experimental group

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.

Treatment:

Drug: 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)

Dose Group 0 (n=8)

Placebo Comparator group

Description:

On the day of administration, subjects will be randomized to receive placebo (n=8) 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.

Treatment:

Drug: Dose Group 0 (n=8)

0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)

Active Comparator group

Description:

On the day of administration, subjects will be randomized to receive the investigational product (0.04 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.

Treatment:

Drug: 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)

0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6)

Active Comparator group

Description:

On the day of administration, subjects will be randomized to receive the DGPR1008 Injection (0.08 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.

Treatment:

Drug: 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6)