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

Start Date17 Jun 2024

Sponsor / Collaborator

Norroy Bioscience Co., LTD

CTR20241620 / RecruitingPhase 1/2

68Ga-NYM005 注射液制备用药盒标记的镓[68Ga]-NYM005 注射液在健康受试者、转移性肾透明细胞癌患者体内的药代动力学、生物分布、辐射剂量和安全性研究

[Translation] Pharmacokinetics, biodistribution, radiation dose, and safety of gallium [68Ga]-NYM005 injection labeled with a kit for preparation in healthy subjects and patients with metastatic renal clear cell carcinoma

Ⅰa 期主要目的：评估68Ga-NYM005 注射液在健康受试者体内的安全性和辐射安全性。次要目的：（1）评价68Ga-NYM005 注射液在健康受试者体内的药代动力学；（2）评价68Ga-NYM005 注射液在健康受试者体内的生物分布；（3）评价68Ga-NYM005 注射液在健康受试者体内的图像质量。 Ⅰb/Ⅱa 期主要目的：评估68Ga-NYM005 注射液在转移性肾透明细胞癌患者体内的安全性和辐射安全性。次要目的：（1）评价68Ga-NYM005 注射液在转移性肾透明细胞癌患者体内的药代动力学；（2）评价68Ga-NYM005 注射液在转移性肾透明细胞癌患者体内的生物分布；（3）评价68Ga-NYM005 注射液在转移性肾透明细胞癌患者体内的图像质量；（4）评价68Ga-NYM005 注射液在转移性肾透明细胞癌患者体内的诊断效能。

[Translation]

Phase Ia Primary objective: To evaluate the safety and radiation safety of 68Ga-NYM005 injection in healthy subjects. Secondary objectives: (1) To evaluate the pharmacokinetics of 68Ga-NYM005 injection in healthy subjects; (2) To evaluate the biodistribution of 68Ga-NYM005 injection in healthy subjects; (3) To evaluate the image quality of 68Ga-NYM005 injection in healthy subjects. Phase Ib/IIa Primary objective: To evaluate the safety and radiation safety of 68Ga-NYM005 injection in patients with metastatic renal clear cell carcinoma. Secondary objectives: (1) To evaluate the pharmacokinetics of 68Ga-NYM005 injection in patients with metastatic clear cell renal carcinoma; (2) To evaluate the biodistribution of 68Ga-NYM005 injection in patients with metastatic clear cell renal carcinoma; (3) To evaluate the image quality of 68Ga-NYM005 injection in patients with metastatic clear cell renal carcinoma; (4) To evaluate the diagnostic efficacy of 68Ga-NYM005 injection in patients with metastatic clear cell renal carcinoma.

Start Date17 Jun 2024

Sponsor / Collaborator

Norroy Bioscience Co., LTD

NCT06613269 / RecruitingPhase 2IIT

Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.

Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.

Start Date27 Mar 2024

Sponsor / Collaborator

Peking Union Medical College Hospital

[+1]

100 Clinical Results associated with 68Ga-NY104

100 Translational Medicine associated with 68Ga-NY104

100 Patents (Medical) associated with 68Ga-NY104

Literatures (Medical) associated with 68Ga-NY104

01 Aug 2023·European journal of nuclear medicine and molecular imaging

Preclinical and pilot clinical evaluation of a small-molecule carbonic anhydrase IX targeting PET tracer in clear cell renal cell carcinoma.

Article

Author: Xing, Haiqun ; Zhu, Wenjia ; Zheng, Guoyang ; Huo, Li ; Ji, Zhigang ; Bai, Chunmei ; Li, Xiaoyuan ; Zhang, Yushi ; Zhang, Haiqiong

PURPOSEClear cell renal cell carcinoma (ccRCC) highly expresses carbonic anhydrase IX (CAIX). The purpose of this study was to evaluate ⁶⁸Ga-NY104, a small-molecule CAIX-targeting PET agent, in tumor models of ccRCC and patients diagnosed with confirmed, or suspicious, ccRCC.METHODSThe in vivo and ex vivo biodistribution of ⁶⁸Ga-NY104 was investigated in CAIX-positive OS-RC-2 xenograft-bearing models. The binding of the tracer was further validated using autoradiography for human ccRCC samples. In addition, three patients with confirmed or suspicious ccRCC were studied.RESULTSNY104 can be labeled with high radiochemical yield and purity. It quickly cleared through kidney with α-half-life of 0.15 h. Discernible uptake is noted in the heart, lung, liver, stomach, and kidney. The OS-RC-2 xenograft demonstrated intense uptake 5 min after injection and gradually increased until 3 h after injection with ID%/g of 29.29 ± 6.82. Significant binding was detected using autoradiography on sections of human ccRCC tumor. In the three patients studied, ⁶⁸Ga-NY104 was well-tolerated and no adverse events were reported. Substantial accumulation was observed in both primary and metastatic lesions in patient 1 and 2 with SUVmax of 42.3. Uptake in the stomach, pancreas, intestine, and choroid plexus was noted. The lesion in third patient was correctly diagnosed as non-metastatic for negative ⁶⁸Ga-NY104 uptake.CONCLUSION⁶⁸Ga-NY104 can efficiently and specifically bind to CAIX. Given the pilot nature of our study, future clinical studies are warranted to evaluate ⁶⁸Ga-NY104 for detection of CAIX-positive lesions in patients with ccRCC.TRIAL REGISTRATIONThe clinical evaluation part of this study was retrospectively registered at ClinicalTrial.gov (NCT05728515) as NYPILOT on 6 Feb, 2023.

100 Deals associated with 68Ga-NY104

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Cell Carcinoma	Phase 2	CN	Norroy Bioscience Co., LTD	17 Jun 2024
Metastatic Clear Cell Renal Cell Carcinoma	Phase 1	CN	Norroy Bioscience Co., LTD	17 Jun 2024

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