177Lu-DOTA-girentuximab (TLX250) / Telix, China Grand Pharma - LARVOL DELTA

Phase 3 study to assess the safety and efficacy of 177Lu-girentuximab in advanced, relapsed or recurrent ccRCC (LUTEON) (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Clear Cell Renal Cell Carcinoma • Oncology

Phase 3 study to assess the safety and efficacy of 177Lu-girentuximab in advanced, relapsed, or recurrent ccRCC (LUTEON). (ASCO 2026) - P3 | "The primary endpoint of Part 2 is progression-free survival, defined as time from randomization to first disease progression according to RECIST 1.1 or death due to any cause. This study is sponsored by Telix Pharmaceuticals."

Clinical • IO biomarker • Metastases • P3 data • Clear Cell Renal Cell Carcinoma • CA9

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

Phase 3 Study to Assess the Safety and Efficacy of 177Lu-girentuximab in Advanced, Relapsed or Recurrent ccRCC (LUTEON; NCT07197580) (KCRS 2026) - P3 | "Previous study results support further investigation into efficacy of 177Lu-girentuximab in these patients. References: Stillebroer 2012 JNM; Stillebroer 2013 EurUrol; Muselaers 2016 EurUrol Conclusions N/A Keywords ccRCC, girentuximab, lutetium-177"

Clinical • Metastases • P3 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Solid Tumor • CA9

Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer (GlobeNewswire) - "LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC. The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh."

Trial status • Clear Cell Renal Cell Carcinoma

Phase 3 study to assess safety and efficacy of 177Lu-girentuximab in advanced relapsed or recurrent ccRCC (LUTEON) (SNMMI 2026) - P3 | "The rapid disease progression experienced by patients in late-line ccRCC treatment necessitates improved therapeutic options. Previous study results support further investigation into the efficacy of 177Lu-girentuximab in this patient population. This study is sponsored by Telix Pharmaceuticals."

Clinical • IO biomarker • Metastases • P3 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Solid Tumor • CA9

Phase 3 study to assess safety and efficacy of 177Lu-girentuximab in advanced relapsed or recurrent ccRCC (LUTEON) (SNMMI 2026) - P3 | "The rapid disease progression experienced by patients in late-line ccRCC treatment necessitates improved therapeutic options. Previous study results support further investigation into the efficacy of 177Lu-girentuximab in this patient population. This study is sponsored by Telix Pharmaceuticals."

Clinical • IO biomarker • Metastases • P3 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Solid Tumor • CA9

Therapeutics Business Unit:…TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) (PRNewswire) - "Telix has opened its first clinical site and is recruiting patients for Part 1 of LUTEON, a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC. Trial recruitment will initially focus ex-U.S."

Trial status • Clear Cell Renal Cell Carcinoma

LUTEON: Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC (clinicaltrials.gov) - P3 | N=40 | Recruiting | Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2026 ➔ Aug 2027

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

TLX250-Tx (177Lu-DOTA-girentuximab) (The Manila Times) - "Telix is commencing site activations ahead of opening patient enrollment in LUTEON10, its pivotal trial of TLX250-Tx as a monotherapy in metastatic clear cell renal cell carcinoma (ccRCC). The study will initially recruit ex-U.S...In January 2026, Telix participated in an additional Type A meeting to address clinical comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the product from scaled-up manufacturing intended for commercial use. Following this meeting, Telix believes it has alignment with the Agency on all key resubmission aspects. Telix will provide a further update on receipt of official FDA minutes from both meetings."

FDA event • Trial status • Clear Cell Renal Cell Carcinoma

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

Development of a multi-functional CAIX-TGFβ targeted radiopharmaceutical for triple-negative breast cancer (AACR-NCI-EORTC 2025) - "Radiation-induced blood cell cytotoxicity at the early stage may require treatment optimization or additional cell survival factors to alleviate the early cytotoxicity. Overall, Lu-177 labeled TLX250-TRAP enables theranostic use to track tumors and promotes therapeutic antitumor immune responses in TNBC."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CA9 • CD4 • CD8 • TGFB1

TLX250-CDx (Zircaix) Included in Leading International Guidelines for Renal Imaging (Telix Press Release) - "The panel asserts that antibody-based radiotracers exhibit lower renal clearance, thereby improving visualization of renal masses. It emphasizes that TLX250-CDx PET 'appears to be a well-tolerated and accurate method for non-invasive identification of ccRCC6' and notes by contrast, the high renal excretion with 18F-FDG PET, which obscures accurate lesion detection...The panel references data from Telix’s pivotal Phase 3 ZIRCON trial..."

Clinical guideline • Clear Cell Renal Cell Carcinoma

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

Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: NYU Langone Health | Not yet recruiting ➔ Recruiting

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

Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: NYU Langone Health

New P1 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

LUTEON: Study of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC (clinicaltrials.gov) - P3 | N=40 | Not yet recruiting | Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

New P3 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

STARLITE-1: 177Lu-girentuximab, cabozantinib & nivolumab in ccRCC (YouTube) - "Eric Jonasch, MD... describes the Phase Ib/II STARLITE-1 trial (NCT05533242) of 177Lu-girentuximab with cabozantinib and nivolumab in treatment-naïve patients with advanced clear cell renal cell carcinoma (ccRCC)."

Video

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

ASCO 2025: 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) (UroToday) - "The STARLITE 2 trial is a phase 2, open-label, single-arm study evaluating the combination of lutetium-177 (¹⁷⁷Lu)-girentuximab and nivolumab in patients with previously treated ccRCC. The study includes a safety lead-in phase to determine the maximum tolerated dose (MTD) of ¹⁷⁷Lu-girentuximab in combination with nivolumab, starting at 75% of the single-agent ¹⁷⁷Lu dose. Once the MTD is established, a Simon two-stage design will be implemented to assess the efficacy of this combination. Patients treated at the MTD during the safety lead-in will be included in the first stage of the phase 2 portion. Notably, the prespecified number of dose-limiting toxicities (DLTs) was exceeded in cohort 2, leading to a dose adjustment back to 1804 MBq/m²."

Clinical protocol • Clear Cell Renal Cell Carcinoma

Telix at ANZSNM Annual Scientific Meeting 2025 (PRNewswire) - "Telix Pharmaceuticals Limited...announces a strong presence at the 55th Annual Scientific Meeting of the Australian and New Zealand Society of Nuclear Medicine (ANZSNM ASM 2025), to be held in Melbourne, Australia from 23–25 May 2025....Demonstrating its commitment to development and education in theranostics, Telix presentations include: ProstACT Global Phase 3 study of TLX591 (177Lu-rosopatamab tetraxetan), Telix's first-in-class PSMA targeting radio antibody-drug conjugate (rADC) therapy candidate; STARSTRUCK study of TLX250 (177Lu-girentuximab) in combination with peposertib in patients with carbonic anhydrase IX (CAIX)-expressing solid tumors, and a preclinical evaluation of 225Ac-girentuximab in combination with DNA damage response inhibition..."

Clinical data • Preclinical • Castration-Resistant Prostate Cancer

Enhanced radiation therapy outcomes via TGF? inhibition in the tumor microenvironment using bifunctional antibody TLX250-TRAP (ESTRO 2025) - "These findings establish that TLX250-TRAP targets TAA and inhibits TGFβ downstream signaling. They also provide evidence of enhanced therapeutic outcomes when combined with EBRT and anti-PDL1 immune checkpoint inhibition. Therapeutic isotope labeling of TLX250-TRAP shows promising anti-cancer potential through antigen- specific delivery of radiation to tumors combined with TGFβ neutralization."

Biomarker • Tumor microenvironment • Breast Cancer • Hepatology • Oncology • Solid Tumor • CA9

Cost-Effectiveness Analysis of 89-Zr-Girentuximab PET—CT (TLX250) to Guide Management of Small Renal Masses (AUA 2025) - "The use of TLX250 alone is the most cost-effective strategy across a variation of costs and probabilities. TLX250 with reflex RMB for negative scans helps avoid unnecessary treatment of benign SRMs and minimizes risks of untreated malignant SRMs and can be cost effective compared to RMB and empiric PN."

Cost effectiveness • HEOR • Oncology • Solid Tumor