- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Biomarker, Review, Journal: Advances in Imaging-Based Biomarkers in Renal Cell Carcinoma: A Critical Analysis of the Current Literature. (Pubmed Central) - Jan 22, 2023 PET/CT radiotracers, such as F-fluorodeoxyglucose (FDG), I-cG250, radiolabeled prostate-specific membrane antigen (PSMA), and C-acetate, have been reported to improve the identification of histology, grading, detection of metastasis, and assessment of response to systemic therapy, and to predict oncological outcomes...Radiomics and radiogenomics are used to complement risk classification models to predict oncological outcomes. Imaging-based biomarkers hold strong potential in RCC, but require standardization and external validation before integration into clinical routines.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus, Opdivo (nivolumab) / Ono Pharma, BMS
STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti (On Demand | Level 1, West Hall; Poster Board No. N10) - Jan 10, 2023 - Abstract #ASCOGU2023ASCO_GU_711; P2 The trial is currently accruing to the safety lead-in phase. Clinical trial information: NCT05239533.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus, Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment na (On Demand | Level 1, West Hall; Poster Board No. N7) - Jan 10, 2023 - Abstract #ASCOGU2023ASCO_GU_708; 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.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Journal, Epigenetic controller: Integrated DNA Methylation/RNA Profiling in Middle Temporal Gyrus of Alzheimer's Disease. (Pubmed Central) - Jan 4, 2023 Furthermore, the CpG site cg25038311 was negatively correlated with the expression of 22 genes...Our results confirm and extend the previous EWAS, providing new information about a brain region not previously explored in AD DNA methylation studies. The relationship between DNA methylation and gene expression is not significant for most of the genes in our sample, consistently with the complexities in the gene expression regulation.
- |||||||||| Enrollment closed, Trial completion date, Trial primary completion date: 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (clinicaltrials.gov) - Nov 10, 2022
P3, N=252, Active, not recruiting, This study shows the predictive value of the "W&W-criteria" for WW duration and shows the potential of [18F]FDG-PET/CT to further improve this. Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Intraoperative dual-modality imaging in clear cell renal cell carcinoma (Green Area, Room 5) - May 23, 2022 - Abstract #EAU2022EAU_2835; This present study demonstrates the feasibility of tumor-targeted dual modality imaging using 111In-girentuxmab-IRDYe800CW in renal surgery. Additionally, it describes the potential value of real-time monitoring of surgical margins in aiding surgical decision making.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
CAIX-specific CAR-NK targeting renal cell carcinoma (Purple Area, Room Elicium 1) - May 23, 2022 - Abstract #EAU2022EAU_2584; Additionally, it describes the potential value of real-time monitoring of surgical margins in aiding surgical decision making. Our results suggest that NK cells can eridicate RCC cells in vivo and possibly this effect can be further enhanced by the use of CAIX-CAR-NK.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
89Zr-girentuximab positron emission tomography in clear cell renal cell carcinoma: Safe and accurate (Purple Area, Room Elicium 1) - May 23, 2022 - Abstract #EAU2022EAU_2483; 89Zr-girentuximab PET/CT imaging is an accurate and noninvasive method that can distinguish ccRCC from non-ccRCC. Furthermore, this study provided valuable safety data on the administration of 89Zr-girentuximab, which was necessary to initiate the multi-center phase III study (ZIRCON).
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - May 5, 2022 P=N/A, N=17, Active, not recruiting, Furthermore, this study provided valuable safety data on the administration of 89Zr-girentuximab, which was necessary to initiate the multi-center phase III study (ZIRCON). Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2022 --> Apr 2023
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Review, Journal: Novel Imaging Methods for Renal Mass Characterization: A Collaborative Review. (Pubmed Central) - Apr 20, 2022 A number of novel imaging tools stand poised to aid in the noninvasive characterization of indeterminate renal masses. In the future, these tools may aid in patient management by providing a comprehensive virtual biopsy, complete with information on tumor histology, underlying molecular abnormalities, and ultimately disease prognosis.
- |||||||||| Adjuvant systemic treatment for renal cancer after surgery: a network meta-analysis (Room 222) - Apr 10, 2022 - Abstract #AUA2022AUA_1546;
Conclusions : Pembrolizumab and pazopanib were the only two adjuvant agents that improved time to disease recurrence compared to observation, with the former likely being the most efficacious. None of the treatments improved overall survival and almost all increased severe adverse events.
- |||||||||| Enrollment open, Trial completion date, Trial primary completion date: Intraoperative Dual-modality Imaging in Renal Cell Carcinoma (clinicaltrials.gov) - Sep 29, 2021
P1, N=30, Recruiting, Trial completion date: Aug 2021 --> Dec 2022 | Initiation date: May 2021 --> Sep 2021 | Trial primary completion date: Aug 2021 --> Dec 2022 Active, not recruiting --> Recruiting | Trial completion date: Jun 2019 --> Apr 2022 | Trial primary completion date: Apr 2019 --> Dec 2021
- |||||||||| Trial completion, Phase classification, Enrollment change, Trial completion date, Trial primary completion date: ZIRDAC-JP: Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC (clinicaltrials.gov) - Aug 23, 2021
P1, N=6, Completed, [In]-girentuximab-F(ab') specifically targets CAIX-expressing areas in HNSCC xenografts, but differences in vessel density and necrosis most likely affected tracer uptake in the tumors and therefore complicated quantification of changes in CAIX expression. Recruiting --> Completed | Phase classification: P1/2 --> P1 | N=40 --> 6 | Trial completion date: Aug 2021 --> Apr 2021 | Trial primary completion date: Jun 2021 --> Oct 2020
- |||||||||| Trial completion date, Trial primary completion date: 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (clinicaltrials.gov) - Aug 18, 2021
P3, N=252, Recruiting, Recruiting --> Completed | Phase classification: P1/2 --> P1 | N=40 --> 6 | Trial completion date: Aug 2021 --> Apr 2021 | Trial primary completion date: Jun 2021 --> Oct 2020 Trial completion date: Oct 2021 --> May 2022 | Trial primary completion date: May 2021 --> Dec 2021
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Clinical, Journal: A genome-wide association study of severe asthma exacerbations in Latino children and adolescents. (Pubmed Central) - Jul 4, 2021 Thus, SNP rs2253681 was significantly associated with both DNA methylation of a cis-CpG in FLJ22447 and severe asthma exacerbations in Latino youth. This may be partly explained by changes in airway epithelial expression of a gene recently implicated in atopic asthma in Puerto Rican children and adolescents (KCNJ2-AS1).
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