Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients

NCT06389682 | Completed Phase 1 FDA Drug

• 1 other identifier: CP-2023-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma

Conditions

Clear Cell Renal Cell Carcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  5 days

Study Arms (1)

68Ga-NYM005 injection

EXPERIMENTAL

Drug: 68Ga-NYM005 injection

Interventions

68Ga-NYM005 injection DRUG

he radiation dose is about 2-7 mCi for a single patient.Using a syringe to withdraw 68Ga-NYM005 injection, the dose will be administered via an intravenous injection and the injection time will be about 45-60 seconds.

68Ga-NYM005 injection

Eligibility Criteria

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

You may qualify if:

• Patients with pathologically confirmed metastatic renal clear cell carcinoma;
• Age range from 18 to 75 years old (including 18 and 75 years old);
• ECOG score of 0 or 1;
• Expected life \> 6 months;
• GFR\> 60 ml/min;
• Women of childbearing age need to have a negative pregnancy test, and the subjects(including male subjects)agree to take effective contraceptive measures during the study period and for at least three months after the drug 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:

• Pregnant or lactating women, or women who plan to conceive during the study period or within three months after drug administration;
• Known or suspected to be allergic to the investigational drug or any of its components,acetazolamide or other sulfonamides:
• 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;
• On VEGF TKI treatment less than 7 days before 68Ga-NYM005 PET/CT, such as sunitinib,sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM005 PET/CT is required;
• Planned (for the period between injection of 68Ga-NYM005 and imaging) antineoplastic therapies;
• 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

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

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 17, 2024
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (2)