Evaluating global clinical trials and development trends of antibody-drug conjugates

Antibody-drug conjugates (ADCs) represent a breakthrough in tumor-targeted therapy, showing promise in both solid tumors and hematological malignancies. By 1 September 2025, more than 370 ADC candidates had entered clinical development, 17 unique products had received at least one regulatory approval worldwide, and more than 150 candidates had been discontinued. This study analyzes 3,077 ADC trials from Citeline Trialtrove, revealing that most trials are concentrated in the United States and China. At the data cutoff, 35% of trials were ongoing and 12% were classified as terminated in Trialtrove. ADC trials primarily focused on solid tumors, with brentuximab vedotin, disitamab vedotin, and gemtuzumab ozogamicin being the most frequently investigated agents. Early-phase trials predominated, whereas Phase III and IV trials were less frequent. EGFR, BRCA1, and TP53 were frequently recorded across trial-design and outcome-related fields. Future research should focus on advancing later-phase trials, refining safety and efficacy, and exploring new therapeutic targets with continued biomarker integration.

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Publication Details

Journal
Biomarker Research
Published
2026-08-28
DOI
https://doi.org/10.1186/s40364-026-00994-0
Primary Topic
HER2/EGFR in Cancer Research
Type
article
Field-Weighted Citation Impact
0.00

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article

Evaluating global clinical trials and development trends of antibody-drug conjugates

Jintao Hu, Zi Yan, Kewei Xu, Cong Lai et al.
Biomarker Research
HER2/EGFR in Cancer Research
article

Evaluating global clinical trials and development trends of antibody-drug conjugates

Jintao Hu, Zi Yan, Kewei Xu, Cong Lai, Chunnuan Deng, Wang He, Cheng Liu, Junjie Wang, Zhihan Yuan
article en

Abstract

Antibody-drug conjugates (ADCs) represent a breakthrough in tumor-targeted therapy, showing promise in both solid tumors and hematological malignancies. By 1 September 2025, more than 370 ADC candidates had entered clinical development, 17 unique products had received at least one regulatory approval worldwide, and more than 150 candidates had been discontinued. This study analyzes 3,077 ADC trials from Citeline Trialtrove, revealing that most trials are concentrated in the United States and China. At the data cutoff, 35% of trials were ongoing and 12% were classified as terminated in Trialtrove. ADC trials primarily focused on solid tumors, with brentuximab vedotin, disitamab vedotin, and gemtuzumab ozogamicin being the most frequently investigated agents. Early-phase trials predominated, whereas Phase III and IV trials were less frequent. EGFR, BRCA1, and TP53 were frequently recorded across trial-design and outcome-related fields. Future research should focus on advancing later-phase trials, refining safety and efficacy, and exploring new therapeutic targets with continued biomarker integration.

Biomarker ResearchVol. 14(1)
Xinjiang Medical University (CN), Sun Yat-sen University (CN), Fifth Affiliated Hospital of Xinjiang Medical University (CN), Guangdong Province Stomatological Hospital (CN), Sun Yat-sen Memorial Hospital (CN), Guangdong Provincial Center for Disease Control and Prevention (CN), Southern Medical University (CN)
National Natural Science Foundation of China, Science and Technology Planning Project of Guangdong Province
Openalex Percentile: Top 13%
HER2/EGFR in Cancer Research
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