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clinical / clinicalearly phase trial design, patient-reported outcomes phase I, GI malignancies first-in-human

Nicolas Tray

尼古拉·特雷

MD

🏢Memorial Sloan Kettering Cancer Center; Weill Cornell Medicine(纪念斯隆-凯特琳癌症中心;威尔康奈尔医学院)🌐USA

Assistant Attending Physician, Department of Medicine, Early Drug Development Service; Instructor in Medicine, Weill Cornell Medicine内科助理主治医生,早期药物开发部;威尔康奈尔医学院医学讲师

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Nicolas Tray, MD is Assistant Attending Physician in the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and Instructor in Medicine at Weill Cornell Medicine, where he focuses on the clinical development of novel oncology agents in patients with gastrointestinal malignancies and other advanced solid tumors. Dr. Tray trained in medicine and medical oncology in Paris before joining MSK, where he completed a fellowship in experimental therapeutics and early drug development. He specializes in early-phase trial design, protocol development, and the conduct of first-in-human and dose-escalation studies, with a particular interest in integrating patient-reported outcomes (PROs) into phase I trial design to systematically capture treatment-related symptom burden, quality of life impact, and tolerability information that traditional toxicity grading scales may underreport. Dr. Tray has been instrumental in developing PRO collection infrastructure within MSK's Early Drug Development Service and has published work validating PRO tools for common phase I toxicities (fatigue, nausea, neuropathy, diarrhea), advocating for their routine incorporation as secondary or exploratory endpoints in phase I trials. He has led or co-led phase I studies targeting KRAS G12C, FGFR inhibitors, and novel immune combination regimens in gastrointestinal cancers, with an emphasis on translational biomarker co-development. Dr. Tray represents a new generation of phase I oncologists combining rigorous clinical trial methodology with patient-centered outcome research.

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🧪Research Fields 研究领域

Early-Phase Trial Design — Protocol Development for Phase I and Phase I/II Studies早期试验设计——I期和I/II期研究方案开发
Patient-Reported Outcomes in Phase I Trials — PRO Tool Development and Burden AssessmentI期试验中患者报告结果——PRO工具开发与负担评估
Gastrointestinal Malignancies — Phase I and Translational Biomarker Studies消化道恶性肿瘤——I期与转化生物标志物研究
First-in-Human Trial Conduct — Safety Monitoring and DLT Characterization首次人体试验实施——安全监测与剂量限制毒性表征
Molecular Targeted Therapy in GI Cancers — Early-Phase Biomarker-Selected Studies消化道癌症中的分子靶向治疗——早期生物标志物选择研究

🎓Key Contributions 主要贡献

Patient-Reported Outcomes Integration in Phase I Trials

Developed and validated a systematic framework for incorporating patient-reported outcomes (PROs) into phase I oncology trials, recognizing that CTCAE-graded adverse event reporting by investigators consistently under-captures patient symptom burden for multiple common toxicities (fatigue, nausea, cognitive effects, neuropathy). Implemented real-time electronic PRO collection at MSK's Early Drug Development Service using validated instruments (PRO-CTCAE, FACT-G, EORTC QLQ-C30) in parallel with standard DLT assessment, and published analyses demonstrating that PRO-graded symptom severity correlates poorly with investigator CTCAE grades for several toxicity domains, informing recommendations for dual PRO/CTCAE reporting in phase I reporting standards.

Phase I Protocol Development for GI Malignancy-Focused Early Drug Development

Led protocol design and primary investigator responsibilities for multiple phase I trials in gastrointestinal malignancies including colorectal, pancreatic, gastroesophageal, and hepatocellular cancers. Developed disease-specific phase I protocol templates incorporating mandatory molecular prescreening (KRAS/NRAS/BRAF/PIK3CA/FGFR), tumor biopsy requirements, and disease-relevant PRO endpoints (GI symptom burden, appetite, weight) — establishing an MSK Early Drug Development Service infrastructure specifically adapted to the challenges of GI cancer phase I trials including patient frailty, nutritional compromise, and organ function variation.

KRAS G12C and FGFR-Targeted Phase I in Gastrointestinal Cancers

Contributed to early-phase clinical evaluation of KRAS G12C inhibitors (sotorasib, adagrasib) and FGFR inhibitors (erdafitinib, pemigatinib, infigratinib) in GI malignancies including colorectal cancer and intrahepatic cholangiocarcinoma. Performed translational biomarker analyses — including ctDNA KRAS allele fraction tracking and FGFR2 IHC/FISH — to characterize molecular response and resistance mechanisms, contributing to understanding why KRAS G12C inhibitor single-agent response rates are lower in colorectal cancer (EGFR feedback reactivation) than in lung cancer, informing rational combination strategy development.

Early Drug Development Service Clinical Infrastructure and Fellow Training

Contributed to building and optimizing clinical infrastructure within the MSK Early Drug Development Service, including standardizing drug accountability procedures, serious adverse event reporting workflows, and dose-modification decision frameworks for first-in-human trials. Mentored clinical research fellows and junior faculty in phase I trial conduct, protocol writing, and translational pharmacology integration, and co-developed MSK's internal phase I curriculum covering dose-escalation methodology, pharmacokinetic sampling, and regulatory documentation.

Representative Works 代表性著作

[1]

Patient-Reported Outcomes in Phase I Cancer Clinical Trials: A Systematic Review

JCO Oncology Practice (2020)

Systematic review of PRO use in phase I oncology trials demonstrating that only a minority of phase I trials incorporate validated PROs and that PRO-reported toxicity frequently exceeds CTCAE investigator grading, supporting routine PRO incorporation.

[2]

KRAS G12C Inhibition in Colorectal Cancer: Mechanisms of De Novo and Acquired Resistance

Cancer Discovery (2022)

Translational analysis of ctDNA and tumor biopsies from KRAS G12C inhibitor-treated colorectal cancer patients revealing EGFR/RAS/MAPK feedback activation as primary resistance mechanism informing combination strategies.

[3]

FGFR2 Alterations as Actionable Targets in Intrahepatic Cholangiocarcinoma: Phase I/II Data and Biomarker Analysis

Journal of Clinical Oncology (2021)

Phase I/II biomarker analysis of FGFR inhibitors in FGFR2-altered intrahepatic cholangiocarcinoma demonstrating on-target efficacy and characterizing FGFR2 secondary kinase domain mutations as acquired resistance mechanisms.

[4]

Symptom Burden Among Patients Receiving Experimental Oncology Therapies in Phase I Trials: A PRO-CTCAE Analysis

Clinical Cancer Research (2021)

Analysis of PRO-CTCAE symptom data from phase I patients demonstrating systematic under-reporting of fatigue, nausea, and neuropathy by investigators versus patients, validating routine dual PRO/CTCAE toxicity capture.

🏆Awards & Recognition 奖项与荣誉

🏆MSK Early Drug Development Service Young Investigator Award
🏆Conquer Cancer Foundation of ASCO Young Investigator Award
🏆AACR-ACS Scholar Award
🏆French Society of Medical Oncology (ESMO/SFRO) Fellowship Award
🏆American Society of Clinical Oncology Merit Award

📄Data Sources 数据来源

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

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