China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020.
Phase I Study Design and Objectives
The single-arm, open-label Phase I study is expected to enroll 10 patients with uncertain renal masses or suspected recurrence of renal clear cell carcinoma. The study is designed to assess the safety, tolerability, radiation dosimetry, and pharmacokinetics of TLX250-CDx for non-invasive detection of renal clear cell carcinoma through positron emission tomography/computed tomography (PET/CT) imaging.
TLX250-CDx: A Promising Non-Invasive Detection Agent
TLX250-CDx is an investigational product being developed by Telix for the non-invasive detection of clear cell renal cell carcinoma (ccRCC) in patients with “indeterminate renal masses” (IDRMs) identified using MRI/PET scans. The imaging agent has been granted Breakthrough Therapy Designation status by the US FDA, highlighting its potential impact on patient care. Recently, a Phase II extended indication study for the agent has commenced abroad.-Fineline Info & Tech
