Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD) - LARVOL DELTA

A dosimetric study of bladder endocavitary therapy using astatine-211 (EANM 2026) - "This study demonstrates that Monte Carlo simulation enables separate estimation of energy deposition to both residual tumor cells and the cells in the bladder wall following intravesical administration. The results support the strong therapeutic potential of [211At] At-girentuximab (ATO-101TM), combining high efficacy with a favorable safety profile for healthy tissues."

Bladder Cancer • Genito-urinary Cancer • Solid Tumor • CA9

[89Zr]Zr-girentuximab PET-CT imaging to diagnose, characterize, and differentiate clear-cell renal cell carcinoma. (PubMed, Med) - "In the phase 3 ZIRCON trial, [89Zr]Zr-girentuximab positron emission tomography-computed tomography (PET-CT) detected the presence of clear-cell renal cell carcinoma (ccRCC) with a sensitivity of 86% and a specificity of 87% in patients with an indeterminate renal mass undergoing nephrectomy.1 This imaging technique could be a promising tool that could revolutionize the management of small renal masses (SRMs) and ccRCC."

Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naïve patients with advanced clear cell RCC. (ASCO-GU 2023) - "The combination of nivolumab plus cabozantinib was recently approved for the first-line treatment of ccRCC based on the CheckMate 9ER phase 3 study demonstrating improved progression-free survival (PFS) and objective response rate (ORR) in comparison to sunitinib...To explore the effects of the treatment on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET scan with [18F]F-AraG radiotracer as well as biopsies for single cell, spatial transcriptomics and proteomics studies. This investigator initiated trial is supported by Telix Pharmaceuticals and DOD grant W81XWH-22-1-0456."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Renal Cell Carcinoma • CA9

STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients with advanced clear cell renal cell carcinoma (ccRCC). (ASCO 2025) - P2 | "In addition, whole body planar and SPECT imaging will be performed after each 177Lu-girentuximab dose to evaluate distribution, lesion uptake, and dosimetry. The prespecified number of DLTs was exceeded in cohort 2 such that dosing reverted back to 1804 MBq/m2, in which accrual is ongoing."

Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

Phase 1b/2 study of combination 177 Lu girentuximab plus cabozantinib and nivolumab in treatment naive patients with advanced clear cell RCC. (ASCO 2024) - P1/2 | "The combination of nivolumab plus cabozantinib was recently approved for the first-line treatment of ccRCC based on the CheckMate 9ER phase 3 study demonstrating improved progression-free survival (PFS) and objective response rate (ORR) in comparison to sunitinib...Starting with the second cycle, nivolumab and cabozantinib will be added at standard dose. To explore the effects of the treatment on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET scan with 18 F-AraG radiotracer as well as biopsies for single cell, spatial transcriptomics and proteomics studies."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Renal Cell Carcinoma • CA9

89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma - results from phase 3 ZIRCON study (EAU 2023) - No abstract available

P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Results from phase 3 study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma (ZIRCON). (ASCO-GU 2023) - P3 | "Sponsored by Telix Pharmaceuticals. This study confirms that TLX250-CDx PET/CT is well tolerated and can accurately and noninvasively identify ccRCC, with promising utility for designing best management approaches for patients with IDRM. Clinical trial information: NCT03849118."

Late-breaking abstract • P3 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9

STARLITE-1: Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naive patients with advanced clear cell RCC. (ASCO 2025) - P1/2 | "The combination of nivolumab plus cabozantinib was approved for first-line treatment of ccRCC based on the CheckMate 9ER phase 3 study demonstrating improved progression-free survival (PFS) and objective response rate (ORR) in comparison to sunitinib...The sample size was chosen for reasonable operating characteristics to distinguish a desirable CR rate of 18% as better than the standard CR rate of 9%. To explore the effects of the treatment on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET scan with 18F-AraG radiotracer and biopsies will be obtained for single cell, spatial transcriptomics, and proteomics studies."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Renal Cell Carcinoma • CA9

Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naïve patients with advanced clear cell RCC. (ASCO 2023) - "The combination of nivolumab plus cabozantinib was recently approved for the first-line treatment of ccRCC based on the CheckMate 9ER phase III study demonstrating improved progression-free survival (PFS) and objective response rate (ORR) in comparison to sunitinib...After the first cycle, nivolumab and cabozantinib will be added starting with the second cycle at standard dose. To explore the effects of the combination therapy on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET scan with [18F]F-AraG radiotracer as well as biopsies for single cell, spatial transcriptomics and proteomics studies."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Immune Modulation • Renal Cell Carcinoma • CA9

STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients (pts) with advanced clear cell renal cell carcinoma (ccRCC). (ASCO-GU 2023) - P2 | "The trial is currently accruing to the safety lead-in phase. Clinical trial information: NCT05239533."

Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9

STARLITE 1: Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naïve patients with advanced clear cell RCC (KCRS 2023) - No abstract available

Clinical • Metastases • P1/2 data • Renal Cell Carcinoma

STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients with advanced clear cell renal cell carcinoma (ccRCC). (ASCO-GU 2025) - P2 | "In addition, whole body planar and SPECT imaging are performed after each 177Lu-girentuximab dose to evaluate distribution, lesion uptake and dosimetry. The pre-specified number of DLTs was exceeded in cohort 2 such that dosing reverted back to cohort 1, in which accrual is ongoing."

Clinical • IO biomarker • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

[89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Our results suggest that [89Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing."

Journal • P3 data • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Solid Tumor • CA9

Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=17 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU) (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Institut Cancerologie de l'Ouest | Trial completion date: Aug 2028 ➔ Jan 2030 | Initiation date: Feb 2026 ➔ Jan 2027 | Trial primary completion date: Aug 2027 ➔ Jan 2029

First-in-human • Trial completion date • Trial initiation date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Defining Use Cases for Girentuximab PET/CT in Urologic Oncology: Insights from an SUO Member Survey (AUA 2026) - "Girentuximab PET/CT results significantly polarized decisions for AS of a small renal mass (V1) and interventions for borderline lymphadenopathy (V6), mass of uncertain pathology (V8), and equivocal post-ablation recurrence (V9), suggesting high-value use cases. In other scenarios, PET results did not consistently augment management. These results likely reflect interplay between disease prevalence and procedural risk, stressing the need for further study of Girentuximab in various clinical contexts."

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • CA9

041IC - Should I Order a PET Scan? Integrating Molecular Imaging into Urologic Oncology Clinical Practice: Current Approaches and Future Opportunities (AUA 2026) - "Emphasis will be placed on novel PET radiopharmaceutical agents in combination with CT or MRI for prostate (FDG, Choline, Acetate, NaF, FACBC, PSMA), kidney (Girentuximab, Sestamibi), and bladder (FDG, Choline, Acetate, fibroblast activation protein) as well as testis cancer (FDG)...This multidisciplinary course led by a combination of urologists, nuclear medicine experts, and medical oncologists, will be conducted through a hybrid approach of lectures and attendee participation. Learning Objective 1: Analyze the best available evidence on the current diagnostic imaging options for prostate, kidney, bladder, and testis cancer detection, staging, and follow-up Learning Objective 2: Describe the benefits of combined functional and anatomic information gained through accurate matching of anatomic (CT/MRI) and functional (PET) images Learning Objective 3: Debate the strengths and limitations of emerging molecular imaging techniques compared to existing diagnostic tests..."

Clinical • Bladder Cancer • Genito-urinary Cancer • Testicular Cancer

Performance of [89Zr]girentuximab PET/CT in Predicting the Presence of Any Renal Malignancy: A Reanalysis of the ZIRCON Trial. (PubMed, Eur Urol) - "Other forms of kidney cancer can express the marker that the imaging agent can identify. The additional analysis showed that when positive, 98% of cases were correctly identified as any form of cancer."

Journal • Review • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Papillary Renal Cell Carcinoma • Renal Cell Carcinoma • Solid Tumor • Von Hippel-Lindau Syndrome • CA9

A First In Human Phase I Trial Evaluating safety, tolErability and ResponSe of [211At]At-Girentuximab (ATO-101) in PatiEnts with Non-Muscle-InVasive BladdER CANCEr Refractory to Standard Treatment (PERSEVERANCE EU) (clinicaltrialsregister.eu) - P1 | N=24 | Not yet recruiting | Sponsor: Institut De Cancerologie De L Ouest

First-in-human • New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Phase 1B/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment-naïve patients with advanced clear cell RCC. (ASCO-GU 2026) - P1/2 | "The combination of nivolumab and cabozantinib was approved for first-line treatment of ccRCC, demonstrating an improved progression-free survival (PFS) and objective response rate (ORR) in comparison to sunitinib...Starting with cycle 2, patients will also receive standard-dose nivolumab and cabozantinib. To explore the effects of the treatment on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET/CT with 18F-FAraG radiotracer as along with tumor biopsies for single cell, spatial transcriptomics and proteomics studies."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Renal Cell Carcinoma • CA9

Emerging role of functional imaging in renal cell carcinoma: from morphology to molecular phenotyping with PET/computed tomography. (PubMed, Curr Opin Oncol) - "Functional imaging in RCC is shifting from anatomical assessment to molecular characterisation. These advances can better select candidates for local versus systemic treatment, individualise therapy and enable novel theranostics. Further prospective trials should validate their performance and define their place in clinical pathways."

Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9

Staging and imaging-based prognostication in renal cell carcinoma: current guidelines and practical considerations. (PubMed, Abdom Radiol (NY)) - "In addition, we dive into future directions, focusing on the potential integration of advanced technologies (e.g., photon counting CT, 89Zr-Girentuximab positron emission tomography/CT), integration with liquid biopsy, and development of standardized reporting systems focusing on cancer likelihood and aggressiveness (e.g., Kidney Imaging Reporting and Data System). By bridging staging descriptors with prognostic phenotypes, we aim to standardize reports, better inform management, and improve decision-making for patients with RCC."

Journal • Review • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urology

CAT-VHL - Exploring the role of Carbonic Anhydrase IX as diagnostic and Theranostic target in Von-Hippel Lindau disease (clinicaltrialsregister.eu) - P1/2 | N=38 | Not yet recruiting | Sponsor: Ospedale San Raffaele S.r.l.

New P1/2 trial • Oncology • Von Hippel-Lindau Syndrome

89Zr-girentuximab PET/CT Enables Noninvasive Assessment of Indeterminate Renal Masses and Metastatic Clear-Cell Renal Cell Carcinoma. (PubMed, Pharmaceutics) - P | "According to referring physicians, 89Zr-girentuximab PET/CT changed clinical management in six of seven patients and improved patient care in all cases. 89Zr-girentuximab PET/CT provides a noninvasive tool for characterizing indeterminate renal masses and metastatic ccRCC and may improve clinical problem-solving in complex scenarios."

Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • Thrombosis • CA9

Cost-Effectiveness of Incorporating [89Zr]Zr-Girentuximab PET-CT for Characterizing Small Renal Masses. (PubMed, J Urol) - "The phase-3 ZIRCON trial demonstrated the diagnostic utility of [89Zr]Zr-girentuximab positron emission tomography-computed tomography (TLX250-CDx) for detecting clear-cell renal cell carcinoma. The results were robust across sensitivity analyses. Using TLX250-CDx to characterize SRMs followed by confirmatory biopsy of negative cases helps avoid biopsy for nearly 60% of patients and treatment of over two-thirds of benign tumors, minimizes the risk of untreated malignancy (<1%), and is likely cost-effective compared with current conventional practices."

HEOR • Journal • Genito-urinary Cancer • Oncology • Solid Tumor