Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients

NCT06389695 | Completed Phase 1 FDA Drug

• 2 other identifiers: CP-2023-03NYM032D01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  5 days

Study Arms (1)

68Ga-NYM032 injection

EXPERIMENTAL

Drug: 68Ga-NYM032 injection

Interventions

68Ga-NYM032 injection DRUG

The radiation dose is about 3-6 mCi for a single patient.Using a syringe to withdraw 68Ga-NYM032 injection, the dose will be administered via an intravenous injection and the injection time will be about 45-60 seconds.

68Ga-NYM032 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically confirmed prostate cancer;
• Age range from 18 to 75 years old (including 18 and 75 years old);
• ECOG score of 0 or 1;
• Expected life ≥ 6 months；
• The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;
• The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.

You may not qualify if:

• Known or suspected to be allergic to the investigational drug or any of its components;
• Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
• Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
• Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
• Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug；
• Ongoing toxicity \>grade l from previous standard or investigational therapies；
• Patients with active infections during screening;
• Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:

Sponsors & Collaborators

• Norroy Bioscience Co., LTD: lead

Study Sites (2)

Affliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• Fu H, He H, Wang Y, Li W, Luo Y, Chen L, Mi Y, Sun C, Mao Y, Yu C. Preliminary evaluation of a novel PSMA-targeting radiopharmaceutical [68Ga]Ga/[177Lu]Lu-NYM032 for theranostic use in prostate cancer. Eur J Nucl Med Mol Imaging. 2025 Apr;52(5):1671-1684. doi: 10.1007/s00259-024-07046-5. Epub 2025 Jan 2.

  PMID: 39745526 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: June 4, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (2)