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clinical / clinicalearly phase trials

Elena Garralda

埃莱娜·加拉尔达

MD, PhD

🏢Vall d'Hebron Institute of Oncology (VHIO)(巴利·德布龙肿瘤研究所)🌐Spain

Head, Early Drug Development Unit; Associate Investigator, Molecular Oncology Group早期药物开发部主任;分子肿瘤学组副研究员

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Elena Garralda, MD, PhD is Head of the Early Drug Development Unit at Vall d'Hebron Institute of Oncology (VHIO) in Barcelona, one of Europe's premier first-in-human trial centers. She is one of the most productive early-phase trial investigators in Europe, having led or co-led over 100 first-in-human and phase I studies across diverse drug classes including antibody-drug conjugates (ADCs), immune checkpoint inhibitors, bispecific antibodies, and targeted small molecules. Dr. Garralda's unit at VHIO is recognized for its rigorous translational science integration, including mandatory pharmacodynamic biopsies, ctDNA monitoring, and immune profiling in early trials. She led one of the first phase I trials of a KRAS G12C inhibitor in Europe and has been principal investigator on pivotal first-in-human studies for multiple approved or late-stage agents. Her work on immune monitoring in early immunotherapy trials has established frameworks for understanding pharmacodynamic immune activation in the tumor microenvironment during phase I dose escalation. She is a sought-after speaker on innovative phase I trial design and translational endpoints in solid tumors.

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🧪Research Fields 研究领域

First-in-Human Trials首次人体试验
Phase I TrialsI期临床试验
Solid Tumors实体瘤
Antibody-Drug Conjugates抗体偶联药物
Immuno-Oncology Phase I免疫肿瘤学I期
Dose Escalation剂量递增

🎓Key Contributions 主要贡献

First-in-Human ADC Development at VHIO

Led multiple first-in-human trials of novel antibody-drug conjugates at VHIO, generating dose escalation, PK/PD, and early efficacy data that informed subsequent phase II development, including ADCs targeting HER2, TROP2, and novel solid tumor antigens.

Immune Monitoring in Early Immunotherapy Trials

Established systematic immune monitoring programs in phase I immunotherapy trials at VHIO, including paired tumor biopsy analysis of TIL composition, PD-L1 expression dynamics, and T-cell receptor clonality as pharmacodynamic endpoints during dose escalation.

KRAS G12C Inhibitor Phase I Leadership in Europe

Served as principal investigator for European cohorts of the first-in-human KRYSTAL and CodeBreaK trials of KRAS G12C inhibitors, contributing translational data on mechanisms of primary and acquired resistance.

ctDNA as Pharmacodynamic Endpoint in Phase I

Integrated circulating tumor DNA (ctDNA) dynamics as a pharmacodynamic and early efficacy endpoint in phase I trials, demonstrating the utility of ctDNA clearance as an early marker of drug activity during dose escalation.

Representative Works 代表性著作

[1]

First-in-human study of AMG 510 (sotorasib), a KRAS G12C inhibitor, in advanced solid tumors

New England Journal of Medicine (2020)

First-in-human phase I trial of sotorasib (AMG 510) establishing safety, dose escalation, and striking early activity in KRAS G12C-mutant solid tumors, particularly NSCLC and colorectal cancer.

[2]

Integrating immune biomarkers in early-phase immunotherapy trials

Clinical Cancer Research (2021)

Framework for systematic immune monitoring using tumor biopsies and blood-based assays as pharmacodynamic endpoints in phase I immunotherapy dose escalation studies.

[3]

Pharmacodynamic markers in phase I antibody-drug conjugate trials

Annals of Oncology (2022)

Analysis of translational endpoints including target expression, ADC payload markers, and tumor biopsy pharmacodynamics in first-in-human ADC trials across solid tumor types.

🏆Awards & Recognition 奖项与荣誉

🏆ESMO Young Oncologist Award
🏆Spanish Society of Medical Oncology (SEOM) Award for Excellence in Clinical Research
🏆VHIO Distinguished Investigator Award
🏆AACR-AstraZeneca Oncology Research Fellowship

📄Data Sources 数据来源

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

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