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

Evaluation of Safety, Tolerability and Response 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

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

Phase II Trial Compares PET Imaging to Conventional Scans Post-Nephrectomy - Brian Shuch (UroToday) - "Pedro Barata is joined by Brian Shuch to discuss his investigator-initiated phase 2 trial evaluating girentuximab PET-CT imaging for detecting residual disease after nephrectomy in clear cell renal cell carcinoma. Dr. Shuch explains that the study enrolls high-risk patients meeting KEYNOTE-564 criteria within 16 weeks post-surgery, comparing dual PET-CT with intravenous contrast against conventional imaging."

Video

IMPACT OF 89Zr-GIRENTUXIMAB PET/CT VERSUS CONVENTIONAL IMAGING ON CLINICAL DECISION-MAKING IN PATIENTS WITH INDETERMINATE RENAL MASSES (ZIRCON-X) (SUO 2025) - P3 | "Nearly half of patients would have had a change in their clinical management plan based on 89 Zr-girentuximab PET/CT imaging results. This study demonstrates that 89 Zr-girentuximab PET/CT has significant potential to impact clinical decision making in the diagnostic workup of patients presenting with small IRMs. Furthermore, it may offer clinical utility in guiding the escalation or de-escalation of treatment strategies."

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Renal Cell Carcinoma • Solid Tumor

Prospective pilot study with [89Zr]Zr-girentuximab PET/CT: CA-IX imaging in metastatic triple negative breast cancer (OPALESCENCE). (PubMed, Eur J Nucl Med Mol Imaging) - P2 | "[89Zr]Zr-girentuximab PET/CT is a sensitive imaging method and offers promise for novel theranostics for mTNBC patients."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CA9

TLX250-CDx (Zircaix) Included in Leading International Guidelines for Renal Imaging (PRNewswire) - "Professor Brian Shuch, MD...commented, "The recognition of ⁸⁹Zr-girentuximab PET in the SNMMI/EANM/ACNM clinical guidelines reflects a shift toward precision medicine in renal cancer, providing clinicians with a more accurate tool for diagnosis to guide optimal, individualized treatment planning for patients."

Media quote • Renal Cell Carcinoma

STARLITE-1: Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial primary completion date: Oct 2025 ➔ Oct 2027

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

Carbonic Anhydrase IX-Targeting for Radioimmunotherapy in Triple-Negative Breast Cancer (EANM 2025) - "The objective of this study was to evaluate Girentuximab theranostic potential as (i) a diagnostic tool (TLX250-CDx - Zirconium-89-labelled Girentuximab) to identify tumour-specific targeting in TNBC, and (ii) a radioimmunotherapeutic tool (TLX250 - Lutetium-177-labelled Girentuximab) to treat TNBC when given as a single agent or in combination with conventional chemotherapy - Capecitabine. The presented results give first evidence of its ability to effectively target and control tumour growth in a TNBC xenograft model, particularly when combined with chemotherapy. Additional studies are now being conducted to further expand on the therapeutic application of Girentuximab-based RIT in TNBC."

IO biomarker • Breast Cancer • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • CA9

Immunomodulation of the tumour microenvironment by 225Ac-hGirentuximab in a syngeneic murine tumor mode (EANM 2025) - No abstract available

Immunomodulating • Preclinical • Tumor microenvironment • Immunology • Oncology

Preliminary Assessment of 89 Zr-Girentuximab Excretion and Radiation Protection in ccRCC patients undergoing PET/CT imaging (EANM 2025) - No abstract available

Clinical • Clear Cell Renal Cell Carcinoma

Robust self-supervised deep learning reconstruction model for reduced 89 Zr-girentuximab PET scan time [WITHDRAWN] (EANM 2025) - No abstract available

Synergistic Anti-Tumour Effects of 225 Ac-DOTA-Girentuximab Combined with DNA Damage Response Inhibitors in CAIX-Positive Renal Cancer (EANM 2025) - No abstract available

Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9

Girentuximab Imaging in Renal Cancer (EANM 2025) - No abstract available

Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Potential of [89Zr]Zr-girentuximab PET/CT for the routine clinical management of patients with suspicious, unspecified renal lesions (EANM 2025) - "Since the other patient had undergone nephrectomy for renal cell carcinoma several years ago, systemic therapy with immunotherapeutic and antiangiogenic treatments was recommended for that patient. Conclusion Despite our limited experience, we were able to recognize the distinct clinical potential of the [ 89 Zr]Zr-girentuximab PET/CT scan in the management of patients with unspecified renal lesions."

Clinical • IO biomarker • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Renal Cell Carcinoma • Solid Tumor • CA9

Improving Clinical Management of von Hippel-Lindau Syndrome with [ 89 Zr]Zr-DFO-Girentuximab PET Imaging (EANM 2025) - "Conclusion This preliminary experience suggests that CAIX-targeted PET imaging may offer significant advantages in detecting and characterising VHL-related tumours, particularly in anatomically complex or ambiguous settings. The ability of [ 89 Zr]Zr-DFO-Girentuximab PET/CT to identify different lesions subtypes supports CAIX as a promising imaging biomarker for improved surveillance and personalised management in VHL syndrome."

Clinical • Clear Cell Renal Cell Carcinoma • Genetic Disorders • Genito-urinary Cancer • Neuroendocrine Tumor • Pancreatic Cancer • Solid Tumor • Von Hippel-Lindau Syndrome • CA9 • HIF1A • VHL

SNMMI/EANM/ACNM Procedure Standard/Procedure Guideline on the Use of Molecular Imaging for Renal Mass Characterization. (PubMed, J Nucl Med) - "A recent phase III trial (ZIRCON) is widely believed to have laid the groundwork for United States Food and Drug Administration approval of the CAIX monoclonal antibody 89Zr-girentuximab...Further, emerging new targeted radiotracers and techniques such as imaging biomarker discovery with artificial intelligence will bolster those concepts. In this manual, we synthesize key data into a recommended approach."

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

STARBURST: Phase 2 Study of 89 Zr-girentuximab for PET Imaging of Solid Tumors Likely to Express High Levels of Carbonic Anhydrase IX (CAIX) (ASTRO 2025) - "TBD"

IO biomarker • P2 data • Brain Cancer • Breast Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Glioblastoma • Oncology • Renal Cell Carcinoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • CA9

Sentinel lymph node staging in urological cancer surgery: advances in imaging, intra-operative detection and translational research. (PubMed, BJU Int) - "The use of SLNB has transformed nodal staging in PeC, influencing treatment decisions and reducing morbidity in patients undergoing surgery. In other urological malignancies, it has not yet established itself as a standard tool for nodal staging. Its impact on survival, quality of life, and translational research remains to be determined."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Kidney Cancer • Lymphoma • Oncology • Penile Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Testicular Cancer • Urethral Cancer • Urology • MET

Enhanced Antitumor Efficacy of DNA Damage Response Inhibitors Combined with 225Ac-DOTA-girentuximab (SNMMI 2025) - "Lartesertib and peposertib exhibited IC50 values of 3.543 µM and 0.7712 µM, respectively, in SK-RC-52 cells. The IC50 value for 225Ac-DOTA-girentxuimab in SK-RC-52 cells was 0.1505 kBq/mL. Synergy mapping analysis revealed an additive effect between 225Ac-DOTA-girentuximab and lartesertib."

Clinical • Ataxia • Immunology • Movement Disorders • Oncology • Primary Immunodeficiency • CA9

Preclinical evaluation of Zr-89/Lu-177-girentuximab as a CA-IX targeting theranostic agent in metastatic colorectal cancer (SNMMI 2025) - "PET imaging of 89Zr-girentuximab demonstrated high tumour uptake (SUVmax=5.6±0.9) and tumour-to-background ratio (TBR=11.0±1.9) at 168h post-injection (Fig 1a.). Corresponding 18F-FDG tumour uptake was low (SUVmax=0.6±0.1). Mice treated with 177Lu-girentuximab showed inhibited tumour growth from day 8 to 22 post treatment (Fig 1b.), a slower regrowth rate, and a significant median survival increase from 42 days to 68 days (P=0.02), compared with mice that received unlabelled girentuximab (Fig 1c.)."

Metastases • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CA9

Preclinical evaluation of Zr-89/Lu-177-girentuximab as a CA-IX targeting theranostic agent in metastatic colorectal cancer (SNMMI 2025) - "PET imaging of 89Zr-girentuximab demonstrated high tumour uptake (SUVmax=5.6±0.9) and tumour-to-background ratio (TBR=11.0±1.9) at 168h post-injection (Fig 1a.). Corresponding 18F-FDG tumour uptake was low (SUVmax=0.6±0.1). Mice treated with 177Lu-girentuximab showed inhibited tumour growth from day 8 to 22 post treatment (Fig 1b.), a slower regrowth rate, and a significant median survival increase from 42 days to 68 days (P=0.02), compared with mice that received unlabelled girentuximab (Fig 1c.)."

Metastases • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CA9

Comprehensive PET Imaging Strategies for Enhanced Diagnosis and Prognostic Assessment in Clear Cell Renal Cell Carcinoma (ccRCC): A Multi-Tracer Approach (SNMMI 2025) - " We reviewed the clinical applications and diagnostic performance of multiple PET tracers used in ccRCC management, including 18F-FDG, 68Ga- or 18F-PSMA, 68Ga-FAPI, 89Zr-DFO-Girentuximab, 68Ga-Pentixafor, and 68Ga-NYM046 PET/CT... 18F-FDG PET/CT: FDG PET/CT, limited in detecting primary renal lesions due to renal excretion, excels in staging, restaging, and recurrence detection in ccRCC patients. It outperforms conventional imaging in monitoring therapeutic response and metastasis. FDG PET/CT can differentiate tumor thrombus from blood clots, providing prognostic value."

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Infectious Disease • Oncology • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thrombosis • CA9 • CXCR4 • FAP • FOLH1

PET Immune system imaging with 89Zr. (SNMMI 2025) - "Introduction: Zirconium-89 (89Zr) is a radioactive isotope in at least 3 clinical trials1 Additionally, the FDA recently approved 89Zr-girentuximab, ZIRCON study on Renal Cell Cancer...Scan time varies due to crystal type, sensitivity, resolution of the scanner. Good Image quality due to low scatter, short positron range, and uptake specificity."

Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8

Use and Quantitation of 89Zr-girentuximab (SNMMI 2025) - "Sponsored by Clinical Trials Network, Technologist Section"

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

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