Antibody drug conjugates: The dos and don'ts in clinical development

Area of Science:

• Oncology
• Pharmacology
• Biotechnology

Background:

• Antibody Drug Conjugates (ADCs) emerged in the 1990s for targeted cancer treatment.
• ADCs aim to enhance antitumor activity while minimizing normal tissue toxicity.
• The ADC platform has matured significantly, with 11 approved agents and numerous others in development.

Purpose of the Study:

• To review challenges and solutions in the clinical development of ADCs.
• To provide guidance on efficient protocol design for ADC clinical trials.
• To share lessons learned from nearly 30 years of ADC development.

Main Methods:

• Review of clinical trial data and development history of ADCs.
• Analysis of common problems encountered during ADC clinical trials.
• Synthesis of practical recommendations for protocol design and clinical investigation.

Main Results:

• Identification of key issues in ADC clinical development.
• Development of strategies to overcome these challenges.
• Established best practices for designing and conducting ADC clinical trials.

Conclusions:

• ADCs represent a significant advancement in targeted cancer therapy.
• Addressing development challenges is crucial for successful ADC implementation.
• This review offers valuable insights for optimizing future ADC research and clinical application.