First Patient Dosed in Phase II ‘CA-NINE’ Trial of TLX250-CDx for Recurrent Kidney Cancer Detection

The initiation of the Phase II ‘CA-NINE’ trial marks a significant milestone in the development of TLX250-CDx, a novel imaging agent for the detection of recurrent kidney cancer. This trial, conducted by Telix Pharmaceuticals, aims to assess the safety and efficacy of TLX250-CDx in patients who have undergone surgery for kidney cancer and are at risk of recurrence.

The ‘CA-NINE’ trial differentiates itself from previous studies by focusing on the detection of recurrent kidney cancer, a critical unmet need in current management strategies. Current imaging techniques often lack the sensitivity and specificity required to accurately detect recurrent disease, leading to delayed diagnosis and suboptimal patient outcomes. The ‘CA-NINE’ trial seeks to address this challenge by evaluating the performance of TLX250-CDx in this specific patient population.

TLX250-CDx is a zirconium-89 (89Zr) radiolabelled monoclonal antibody that targets carbonic anhydrase IX (CAIX), a tumour-associated antigen highly expressed in clear cell renal cell carcinoma (ccRCC). By binding to CAIX, TLX250-CDx enables the non-invasive detection of ccRCC using positron emission tomography (PET) imaging.

The use of TLX250-CDx in the ‘CA-NINE’ trial has the potential to improve patient outcomes by enabling earlier and more accurate detection of recurrent kidney cancer. This, in turn, can facilitate timely intervention and reduce overtreatment, which is a significant issue in current kidney cancer management. The trial's design accounts for the heterogeneity of kidney cancer and its various subtypes by including patients with different histological types and stages of disease.


The regulatory approval process for TLX250-CDx in recurrent kidney cancer detection is expected to have a significant impact on its market launch timeline. The BLA submission for TLX250-CDx was supported by findings from the phase 3 ZIRCON trial, which demonstrated high specificity and sensitivity of the agent for PET/CT imaging of ccRCC. However, the FDA has requested additional data, which may delay the approval process. Telix Pharmaceuticals is working closely with the FDA to address their concerns and expects to be able to satisfy their requirements within a minimal time frame.

The pricing strategy for TLX250-CDx will play a crucial role in its market penetration. As a novel imaging agent, TLX250-CDx has the potential to offer significant clinical benefits, but its cost-effectiveness will be an essential factor in its adoption. Telix Pharmaceuticals has not yet announced an official pricing strategy for TLX250-CDx, but it is expected to be competitive with existing imaging techniques and reflect the value it brings to patients and healthcare providers.


In conclusion, the initiation of the Phase II ‘CA-NINE’ trial marks an important step in the development of TLX250-CDx as a novel imaging agent for the detection of recurrent kidney cancer. The trial addresses a critical unmet need in current management strategies and has the potential to improve patient outcomes by enabling earlier and more accurate detection of recurrent disease. The regulatory approval process and pricing strategy will be crucial factors in determining the success of TLX250-CDx in the market.