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Antibody-drug conjugates (ADCs) combine monoclonal antibodies and chemotherapeutics to target cancer cells. The clinical development of these complex drugs presents pharmacology challenges. This review analyzes the six FDA-approved ADCs to summarize lessons for optimizing first-in-human dose selection, study design, bioanalytical methods, drug interaction evaluations, modeling approaches, and immunogenicity assessments. Implementing integrated clinical pharmacology strategies for ADCs can enable regulatory approval and ideal use of these emerging targeted cancer therapies. Analysis of approved ADCs reveal key considerations for future ADC programs regarding data integration, modeling, bioanalysis, early clinical trials, dose rationale, and immunogenicity.

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Clinical Pharmacology Considerations in Antibody-Drug Conjugates Development

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  • 发表日期：

    2026年

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  • Chandrasekar Durairaj,
  • Dawei Xuan,
  • Diane Wang

摘要

Antibody-drug conjugates (ADCs) combine monoclonal antibodies and chemotherapeutics to target cancer cells. The clinical development of these complex drugs presents pharmacology challenges. This review analyzes the six FDA-approved ADCs to summarize lessons for optimizing first-in-human dose selection, study design, bioanalytical methods, drug interaction evaluations, modeling approaches, and immunogenicity assessments. Implementing integrated clinical pharmacology strategies for ADCs can enable regulatory approval and ideal use of these emerging targeted cancer therapies. Analysis of approved ADCs reveal key considerations for future ADC programs regarding data integration, modeling, bioanalysis, early clinical trials, dose rationale, and immunogenicity.