The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and Development of Anti-Tumor Antibody Drug Conjugates” and is seeking public feedback for one month. The document aims to provide a framework for the rational design of clinical trials involving antibody drug conjugates (ADCs) for anti-tumor treatments.
Key Principles and Requirements
The guidelines outline principles for the rational design of ADC-related clinical trials, emphasizing that these should be based on clinical needs. Specific requirements are set for the selection of target antigens, antibodies, linkers, payloads, and coupling methods. The document also highlights key points of concern during the clinical development of ADCs, including differences in efficacy between different drugs targeting the same antigen, differences in efficacy of the same drug for different antigen expression statuses, and the exploration of optimal dosing regimens.
Safety and Combination Therapy
The guidelines address safety considerations, such as off-target effects and other risks associated with ADCs. Additionally, they support the exploration of combination therapies, which could enhance the efficacy and safety profiles of these treatments. The release of these guidelines underscores the CDE’s commitment to advancing the development of innovative anti-tumor therapies.-Fineline Info & Tech
