International Phase II Study to Identify Biomarkers Predicting Resistance and Response to Antibody-Drug Conjugates in Patients With Advanced Solid Tumors Treated by Standard Therapies

What this Trial Is About

Researchers are investigating how specific biomarkers relate to resistance against Antibody-Drug Conjugates ADCs, a targeted cancer treatment used for various solid tumors such as advanced breast, gastric, urothelial, and non-small cell lung cancers. This international Phase II trial aims to improve understanding of why some tumors resist ADCs and to identify biomarkers that predict response and toxicity, helping personalize treatment choices. The study also addresses the complex biology of ADCs and the impact of patient factors on treatment side effects to improve quality of life during therapy. Participants receive standard-of-care ADC treatments including trastuzumab deruxtecan T-DXd, trastuzumab emtansine T-DM1, sacituzumab govitecan SG, or enfortumab vedotin EV according to current clinical indications. The trial includes both retrospective analysis of past patients and prospective enrollment, with collection of tumor tissue, blood, and other biological samples before, during, and after treatment. Patient-reported outcomes are collected via questionnaires. Advanced laboratory techniques and machine-learning models will be used to analyze biomarker data and develop a score predicting ADC efficacy and toxicity. Throughout an average of three years of follow-up, participants undergo regular assessments including biopsies, blood tests, and questionnaires to monitor tumor response, resistance biomarkers, and side effects. Researchers will evaluate multiple outcome measures such as biomarker changes over time, patient quality of life, and treatment costs. This comprehensive approach aims to provide new insights into ADC resistance and toxicity while supporting personalized cancer care. Participants are monitored closely to ensure safety and data are collected to inform future ADC use.

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers