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clinical / clinicalearly phase trials

Jean-Charles Soria

让-夏尔·索里亚

MD, PhD

🏢Gustave Roussy Cancer Campus(古斯塔夫·鲁西癌症中心)🌐France

Chief Medical Officer, Investigational Drug Branch; Former Director, Drug Development Department研究药物部首席医疗官;前药物开发部主任

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h-index
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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Jean-Charles Soria, MD, PhD is Chief Medical Officer of the Investigational Drug Branch and a professor at Gustave Roussy Cancer Campus in Villejuif, France—one of Europe's largest and most prestigious cancer centers. He has been one of the most prominent European phase I trialists of his generation, having led or contributed to first-in-human trials of osimertinib, alectinib, durvalumab, and numerous other oncology agents that subsequently achieved regulatory approval. Dr. Soria built the Drug Development Department (DITEP) at Gustave Roussy into one of the largest early-phase programs in Europe, conducting over 60 concurrent phase I and II trials. He has been a strong proponent of accelerated titration designs and pharmacologically guided dose escalation to improve the efficiency of dose escalation in oncology. His work on molecular predictors of response in phase I—particularly in EGFR-mutant and ALK-rearranged lung cancer—demonstrated the transformative potential of genomic patient selection in first-in-human studies. He co-founded the EORTC Early Clinical Trials Working Group and has contributed extensively to European regulatory science and early-phase trial methodology.

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🧪Research Fields 研究领域

Phase I TrialsI期临床试验
Lung Cancer Drug Development肺癌药物开发
EGFR/ALK InhibitorsEGFR/ALK抑制剂
Early Immunotherapy Trials早期免疫治疗试验
Basket Trials篮子试验
Accelerated Titration Design加速滴定设计

🎓Key Contributions 主要贡献

Osimertinib First-in-Human Development

Served as a principal investigator in the AURA first-in-human study of osimertinib (AZD9291), the third-generation EGFR inhibitor, contributing European patient cohorts and translational analyses on T790M resistance mechanisms and acquired resistance at progression.

DITEP: Building Europe's Largest Phase I Unit

Built and led the Drug Development Department (DITEP) at Gustave Roussy, growing it to one of Europe's largest early-phase units with 60+ concurrent trials, integrated translational science, and a multidisciplinary molecular tumor board guiding trial enrollment.

Accelerated Titration and Adaptive Phase I Designs

Advocated for and implemented accelerated titration designs and model-based dose escalation at Gustave Roussy, reducing the number of patients treated at sub-therapeutic doses and improving efficiency of MTD identification.

Molecular Predictors in Phase I Lung Cancer

Led translational analyses in phase I lung cancer trials identifying molecular determinants of response and resistance to EGFR and ALK inhibitors, helping establish the paradigm of genotype-guided enrollment in first-in-human studies.

Representative Works 代表性著作

[1]

Osimertinib in pretreated T790M-positive advanced non-small-cell lung cancer: AURA study phase II extension cohort

Journal of Clinical Oncology (2016)

Phase II expansion cohort from the AURA first-in-human trial demonstrating high response rate of osimertinib in T790M-positive NSCLC, leading to accelerated FDA approval.

[2]

Phase I study of durvalumab (MEDI4736), anti-PD-L1 antibody, in patients with advanced solid tumors

Journal of Clinical Oncology (2018)

First-in-human and dose expansion study of durvalumab in solid tumors, establishing safety, optimal dosing, and early activity signals that supported pivotal trial development.

[3]

Drug development in oncology: addressing heterogeneity and guiding precision

Nature Reviews Cancer (2017)

Perspective on integrated molecular profiling, adaptive designs, and translational science frameworks to improve efficiency and patient benefit in early-phase oncology drug development.

🏆Awards & Recognition 奖项与荣誉

🏆ESMO Award for Translational Research
🏆French National Academy of Medicine Prize
🏆AACR-AstraZeneca Oncology Research Award
🏆ASCO Merit Award

📄Data Sources 数据来源

Last updated: 2026-01-15 | All information from publicly available academic sources

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