Clinical trial NCT06389682: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Clear Cell Renal Cell Carcinoma Metastatic
Lead sponsor: Norroy Bioscience Co., LTD
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affliated Hospital of Jiangnan University
state: Jiangsu
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: