This is a prospective, single-center study aimed at evaluating the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Based on image analysis, this study will assess the uptake of various kinds of tumors using 68Ga-NYM096 PET/CT. The findings will provide critical insights into the tumor uptake on 68Ga-NYM096 PET/CT to identify the most promising indications for future application.

Start Date01 Aug 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT06649682

/ SuspendedPhase 1IIT

Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma

This is a single-center, phase I study. Patients with metastatic clear cell renal cell carcinoma will be recruited in this study to (Phase A) evaluate using 68Ga-NYM096 PET/CT and to (Phase B) treat with 177Lu-NYM096.
The study will be conducted in two phases. The purpose is Phase A: to evaluate the safety, tolerability, and imaging characteristics of 68Ga-NYM096 Phase B: to evaluate the safety, tolerability, and recommended phase 2 dose of 177Lu-NYM096

Start Date21 Nov 2024

Sponsor / Collaborator

Peking Union Medical College Hospital

CTR20262808

/ Not yet recruitingPhase 1

68Ga-NYM096注射液制备用药盒标记的镓[68Ga]-NYM096注射液在不确定性肾肿块参与者体内的安全性、生物分布、辐射剂量学和初步诊断效能评估研究

[Translation] Safety, biodistribution, radiation dosimetry, and preliminary diagnostic efficacy assessment of gallium [68Ga]-NYM096 injection kit-labeled in participants with uncertain renal masses.

主要目的：评估68Ga-NYM096注射液在透明细胞肾细胞癌参与者体内的安全性。次要目的：评估68Ga-NYM096注射液在透明细胞肾细胞癌参与者体内的辐射安全性；评价68Ga-NYM096注射液在透明细胞肾细胞癌参与者体内的药代动力学；评价68Ga-NYM096注射液在透明细胞肾细胞癌参与者体内的生物分布；评估68Ga-NYM096注射液在透明细胞肾细胞癌参与者体内的最佳成像时间点；评估68Ga-NYM096注射液在透明细胞肾细胞癌参与者体内的诊断效能；探索性目的：评估68Ga-NYM096 SUVs与组织学 CAIX 表达程度的相关性。

[Translation]

Primary Objective: To evaluate the safety of 68Ga-NYM096 injection in participants with clear cell renal cell carcinoma. Secondary Objectives: To evaluate the radiation safety of 68Ga-NYM096 injection in participants with clear cell renal cell carcinoma; to evaluate the pharmacokinetics of 68Ga-NYM096 injection in participants with clear cell renal cell carcinoma; to evaluate the biodistribution of 68Ga-NYM096 injection in participants with clear cell renal cell carcinoma; to evaluate the optimal imaging time point for 68Ga-NYM096 injection in participants with clear cell renal cell carcinoma; to evaluate the diagnostic efficacy of 68Ga-NYM096 injection in participants with clear cell renal cell carcinoma. Exploratory Objective: To evaluate the correlation between 68Ga-NYM096 SUVs and histological CAIX expression levels.

Start Date-

Sponsor / Collaborator

Anhui Nuoyu Biopharmaceutical Co., Ltd.

100 Clinical Results associated with 68Ga-NYM096

100 Translational Medicine associated with 68Ga-NYM096

100 Patents (Medical) associated with 68Ga-NYM096

100 Deals associated with 68Ga-NYM096

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Cell Carcinoma	Phase 1	China	Anhui Nuoyu Biopharmaceutical Co., Ltd.	27 Jul 2026
Metastatic Clear Cell Renal Cell Carcinoma	Phase 1	China	Peking Union Medical College Hospital	21 Nov 2024

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