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Clinical Trial Trends: Antibody-Drug Conjugates

Clinical Trial Trends: Antibody-Drug Conjugates

Antibody-drug conjugates (ADCs) are transforming oncology by offering a precise, targeted approach to treatment. Combining the specificity of monoclonal antibodies with the potency of cytotoxic agents, ADCs are designed to selectively target cancer cells while reducing systemic toxicities compared to traditional therapies. As ADCs advance through clinical trials, each phase contributes essential insights into their safety, efficacy, and therapeutic potential. 

The global ADC market has experienced significant growth, with a valuation of $7.35 billion in 2022. Projections indicate this market will exceed $28 billion by 2028, reflecting a compound annual growth rate (CAGR) of 25.4% during the forecast period from 2022 to 2028. This expansion is driven by the increasing prevalence of cancer, advancements in ADC technologies, and a growing pipeline of ADC candidates in clinical development. 

The competitive landscape of the ADC market is marked by substantial licensing agreements and collaborations. Notably, the total licensing deal value for ADCs surged by 400% from 2017 to 2022, reaching a peak of $16.6 billion in 2022. This surge underscores the pharmaceutical industry’s commitment to investing in ADC development and commercialization. Companies are striving to differentiate themselves by exploring novel targets, innovative linker technologies, and optimized payloads to enhance the therapeutic index of ADCs. As of December 2024, there are 15 FDA-approved antibody-drug conjugates targeting 16 different cancer indications. These include both solid tumors (like breast, lung, and bladder cancers) and hematologic malignancies (like lymphomas and leukemia). 

The development of ADCs involves a complex interplay of disciplines, including antibody engineering, cytotoxic drug development, and linker technology. The design of an effective ADC requires careful selection of a target antigen that is predominantly expressed on cancer cells, a potent cytotoxic agent capable of inducing cell death upon internalization, and a stable linker that ensures the conjugate remains intact in circulation but releases the drug upon reaching the target cell. Advancements in each of these components have been pivotal in overcoming previous limitations related to toxicity and efficacy, leading to the current generation of ADCs that offer improved therapeutic outcomes. ADCs offer higher probabilities of technical and regulatory success compared to other oncology drugs, making them attractive for both pharmaceutical companies and investors. The technology is seen as less risky and more modular, encouraging broader applications 

Despite these advancements, challenges like immune-related side effects and payload optimization remain. However, the continued investment and focus on innovation signal a promising future for ADCs in cancer therapy. 

 

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Understanding the Antibody-Drug Conjugate Clinical Trial Landscape  

To get a better idea of what ADC research looks like, we will use Citeline, a clinical trial intelligence platform, to outline what the Antibody-Drug Conjugate clinical trial landscape looks like today. 

Antibody-Drug Conjugate Trials by Status  

To date, there have been over 2,500 Antibody-Drug Conjugate Trials. Just over 1,300 are current. Here is a breakdown by status.  

Antibody-Drug Conjugate Trials by Status  

Citeline Trialtrove® – 22NOV2024  

Trials by Phase  

ADCs as a drug type are newer than many other approaches, so it is no surprise we are seeing a significant number of earlier phase trials, but that balance will shift as time goes on. 

Antibody-Drug Conjugate Trials by Phase  

Citeline Trialtrove® – 22NOV2024  

Antibody-Drug Conjugate Trials by Start Date  

Next, let’s consider Antibody-Drug Conjugate Trials by their start date. While the technology is still somewhat newer, interest in this drug type has been growing every year.

Antibody-Drug Conjugate Trials by Start Date, 2014-2024  

Citeline Trialtrove® – 22NOV2024  

 

Antibody-Drug Conjugate Trials by Country  

Looking at planned and ongoing Antibody-Drug Conjugate Trials by site location is also interesting. Here are the top 10 site locations for this phase research around the world. Rapid increase in ADC trials in China can be attributed to government support for innovative biologics, increasing domestic biopharma capabilities and a large patient pool. Also regulatory reforms in China have accelerated clinical trials approval and facilitated faster market access.   

Planned & Ongoing ADC Trials by Site Country, Top 10  

Countries  

Count  

China 

701 

United States 

515 

Spain 

196 

France 

155 

Italy 

150 

Australia 

148 

South Korea 

142 

Canada 

141 

Japan 

134 

United Kingdom 

131 

Citeline Trialtrove® – 22NOV2024  

 

Precision's Expertise in Antibody-Drug Conjugate Research  

At Precision for Medicine, we have worked on 13 Antibody-Drug Conjugate Trials.   

Trials by Phase  

Looking at our ADC experience below, nearly 80% of our work is in early phase research. 

Precision for Medicine ADC Trials by Phase  

Citeline Trialtrove® – 22NOV2024  
 

Antibody-Drug Conjugate Trial Starts  

Precision’s experience in Antibody-Drug Conjugate goes back 7 years and counting. We have been proud to work on several early trials. 

Precision for Medicine ADC Trials by Start Date, 2014-2024  

Citeline Trialtrove® – 22NOV2024  
 

Precision's Reach in Antibody-Drug Conjugate Research

Precision for Medicine’s ADC trials stretch around the globe.   

Precision for Medicine's Phase 3 Oncology Trials by Site Country  

AttachmentCiteline Trialtrove® – 22NOV2024  
 

Precision's Focus in Antibody-Drug Conjugate Research  

Precision for Medicine’s Antibody-Drug Conjugate experience encompasses solid tumors as well as hematology-oncology trials. 

Precision for Medicine's ADC Trials by Tumor Type  

Citeline Trialtrove® – 22NOV2024  
 

Precision’s experience with ADCs is also balanced between First-In-Human (FIH) trials and non-FIH trials. While we have worked with more non-FIH trials, we have a solid history of working in innovative trials and partnering with sponsors who are seeing their drugs in action for the first time.   

Precision for Medicine's ADC Trials by First-In-Human 

Citeline Trialtrove® – 22NOV2024  

Proceed with Precision

Precision for Medicine offers comprehensive support for ADC clinical trials across all phases, bringing deep expertise in targeted therapies and the unique considerations they require. From early safety assessments to late-phase efficacy studies, our tailored approaches address the challenges of patient selection, biomarker integration, and trial design. 

By partnering with sponsors to navigate complex regulatory landscapes and engage diverse populations, we ensure the smooth progression of ADC trials while accelerating their impact on oncology treatment. Together, we can advance the development of these groundbreaking therapies and improve outcomes for patients worldwide.