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

Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM005 Injection Prepared by Kit for the Preparation of the 68Ga-NYM005 Injection in Patients With Metastatic Clear Cell Renal Carcinoma.

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

Study Overview

• Status: Recruiting
• Conditions: Clear Cell Renal Cell Carcinoma Metastatic
• Intervention / Treatment: Drug: 68Ga-NYM005 injection

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214000
      • Recruiting
      • Affliated Hospital of Jiangnan University
      • Contact: Chunjing Yu; Phone Number: 15312238622; Email: ycj_wxd1978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with pathologically confirmed metastatic renal clear cell carcinoma;
2. Age range from 18 to 75 years old (including 18 and 75 years old);
3. ECOG score of 0 or 1;
4. Expected life > 6 months;
5. GFR> 60 ml/min;
6. 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;
7. 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.

Exclusion Criteria:

1. Pregnant or lactating women, or women who plan to conceive during the study period or within three months after drug administration;
2. Known or suspected to be allergic to the investigational drug or any of its components,acetazolamide or other sulfonamides:
3. 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;
4. 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;
5. 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;
6. Planned (for the period between injection of 68Ga-NYM005 and imaging) antineoplastic therapies;
7. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug;
8. Ongoing toxicity >grade l from previous standard or investigational therapies；
9. Patients with active infections during screening;
10. 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:
11. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-NYM005 injection	Drug: 68Ga-NYM005 injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events	5 days

Collaborators and Investigators

• Sponsor: Norroy Bioscience Co., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: CP-2023-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No