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clinical / clinicalphase I immuno-oncology, biomarker development, clinical trial design, translational oncology, BelgiumBispecific T-cell Engager Pioneer

Sylvie Rottey

西尔维·罗泰

MD, PhD

🏢Ghent University Hospital; Ghent University(根特大学医院;根特大学)🌐Belgium

Professor of Oncology, Ghent University; Head of Drug Research Unit, Ghent University Hospital; Phase I Clinical Investigator根特大学肿瘤学教授;根特大学医院药物研究部负责人;I期临床研究员

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Key Contributions

👥Biography 个人简介

Sylvie Rottey, MD, PhD is Professor of Oncology at Ghent University and Head of the Drug Research Unit at Ghent University Hospital, where she leads one of Belgium's most active early-phase oncology clinical trial programs. As a clinical oncologist with deep expertise in phase I immuno-oncology and translational biomarker development, Dr. Rottey has served as principal investigator on numerous first-in-human and early-phase trials of checkpoint inhibitors, bispecific antibodies, and novel immune combination regimens. Her Drug Research Unit at Ghent University Hospital is a principal investigator site for international multi-center phase I trials, having enrolled patients in early-phase studies of PD-1/PD-L1 inhibitors (including atezolizumab, durvalumab, and avelumab dose escalation studies), TIM-3 and LAG-3 checkpoint inhibitors, antibody-drug conjugates, and cellular therapy. Dr. Rottey's scientific program integrates biomarker development with early-phase clinical trial conduct, prospectively collecting paired tumor biopsies and peripheral blood samples from phase I patients to characterize pharmacodynamic markers of immune activation, T-cell expansion, and target engagement. Her translational research in genitourinary oncology, particularly bladder and renal cell carcinoma, has identified biomarkers of immunotherapy response applicable to clinical stratification. She has contributed to Belgian and European oncology regulatory and clinical trial infrastructure through leadership in EORTC Phase I working groups and the ESMO Clinical Trial Initiative.

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🧪Research Fields 研究领域

Phase I Immuno-Oncology — First-in-Human Trials of Checkpoint Inhibitors and Novel Immune AgentsI期免疫肿瘤学——检查点抑制剂和新型免疫药物的首次人体试验
Biomarker Development — Predictive and Pharmacodynamic Biomarkers for Immunotherapy生物标志物开发——免疫治疗的预测性和药效学生物标志物
Clinical Trial Design — Adaptive and Biomarker-Selected Early-Phase Trial Methodology临床试验设计——自适应和生物标志物选择的早期试验方法
Translational Oncology — Bench-to-Bedside Integration of Tumor Immunology转化肿瘤学——肿瘤免疫学的从基础到临床整合
Genitourinary Oncology — Bladder, Renal, and Prostate Cancer Clinical Research泌尿生殖系统肿瘤学——膀胱癌、肾癌和前列腺癌临床研究

🎓Key Contributions 主要贡献

Phase I Immuno-Oncology Program at Ghent — First-in-Human Immune Agent Trials

Built and leads the Drug Research Unit at Ghent University Hospital as a major European center for phase I immuno-oncology trials, serving as principal investigator on first-in-human and dose-escalation studies of next-generation checkpoint inhibitors (TIM-3, LAG-3, TIGIT antagonists), bispecific T-cell engagers, and novel immune combination regimens. The unit has enrolled hundreds of patients across dozens of first-in-human trials, contributing pivotal safety and preliminary efficacy data that shaped dose selection and expansion cohort design for multiple agents that proceeded to registrational trials.

Translational Biomarker Development for Checkpoint Inhibitor Response

Developed prospective biomarker collection and analysis programs integrated into phase I immuno-oncology trials at Ghent, characterizing on-treatment pharmacodynamic changes in tumor infiltrating lymphocytes, T-cell receptor (TCR) clonality, cytokine profiles, and soluble checkpoint ligand levels as markers of immune activation and drug target engagement. Published translational analyses identifying predictive biomarkers for durable response to PD-1/PD-L1 inhibitors in urothelial and renal cell carcinoma cohorts, contributing to precision patient selection frameworks for immunotherapy.

Genitourinary Oncology — Bladder and Renal Cancer Immunotherapy Research

Led clinical and translational research in urothelial and renal cell carcinoma immunotherapy, contributing to early-phase studies defining the role of checkpoint inhibitors in bladder cancer (atezolizumab, durvalumab, and avelumab), characterizing predictive biomarker correlates (PD-L1, TMB, FGFR3 mutation, genomic subtypes) from pre-treatment tumor biopsies, and publishing translational cohort analyses from multi-institutional collaborative studies. Contributed to EORTC bladder cancer cooperative group studies incorporating biomarker substudies.

European Early-Phase Trial Infrastructure — EORTC and ESMO Leadership

Contributed to European early-phase oncology clinical trial infrastructure through active participation and leadership roles in the EORTC Phase I/II working group, providing expertise in first-in-human trial design, dose escalation methodology, biomarker integration, and regulatory strategy. Contributed to ESMO guidelines on early-phase trial design and patient selection for checkpoint inhibitors, and participated in international consensus processes for defining response assessment criteria and efficacy endpoints in phase I immuno-oncology trials.

Representative Works 代表性著作

[1]

Phase I Study of Atezolizumab (Anti-PD-L1) in Combination with Bevacizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Journal of Thoracic Oncology (2019)

Phase I dose-escalation study characterizing the safety and tolerability of atezolizumab-bevacizumab-chemotherapy combination in advanced NSCLC, contributing to the registrational IMpower150 program.

[2]

Safety and Clinical Activity of Pembrolizumab as First-Line Therapy in Patients with Advanced Urothelial Cancer (KEYNOTE-052)

Lancet Oncology (2017)

Phase II study of pembrolizumab in cisplatin-ineligible advanced urothelial carcinoma with translational biomarker analyses, representing collaborative contributions to the KEYNOTE-052 international study.

[3]

Avelumab Plus Axitinib in Patients with Previously Untreated Advanced Renal Cell Carcinoma

Annals of Oncology (2021)

Analysis of JAVELIN Renal 101 long-term efficacy and biomarker data from avelumab plus axitinib in advanced RCC with biomarker correlation analysis.

[4]

FGFR3 Alterations in Advanced Urothelial Carcinoma — Prevalence, Biology and Clinical Implications

BJU International (2020)

Comprehensive characterization of FGFR3 alterations in urothelial carcinoma with clinical and translational implications for targeted therapy and immunotherapy combination strategies.

🏆Awards & Recognition 奖项与荣誉

🏆Belgian Society of Medical Oncology (BSMO) Clinical Research Award
🏆EORTC Investigator of the Year Award — Phase I Program
🏆Ghent University Hospital Excellence in Clinical Research Award
🏆ESMO Fellowship in Early Drug Development
🏆FWO (Research Foundation Flanders) Senior Research Grant

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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