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The study optimized individualized therapy by using individually dosed drug regimens that co-target multiple molecular alterations, guided by an evidence-based matching score. The trial tested a pan-cancer, N-of-1 strategy and evaluated safety, biomarker matching, disease control, and survival outcomes, linking better matching with improved clinical performance.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/investigation-of-profile-related-evidence-determining-individualized-cancer-therapy-i-predict-n-of-1-precision-oncology-study-molecular-profiling-to-match-individually-dosed-personalized-drug-combinations/344851/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/investigation-of-profile-related-evidence-determining-individualized-cancer-therapy-i-predict-n-of-1-precision-oncology-study-molecular-profiling-to-match-individually-dosed-personalized-drug-combinations/344851.png","ImageObject",300,407,{"name":92,"@type":93},"Olivia Brown","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-24","2026-09-22",true,{"@type":102,"interactionType":103,"userInteractionCount":8},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What problem does I-PREDICT address in precision oncology?","Question",{"text":112,"@type":113},"Many cancers have molecular profiles that do not align neatly with a single tumor type, and most precision oncology treatments match only one biomarker. 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These outcomes did not vary by the number of drugs or starting doses.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},344851,1790293638,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":8,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},16904993612988,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","Original Reports | Genomics/Proteomics  \nInvestigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT) N-of-1 Precision Oncology Study: Molecular Profiling to Match Individually Dosed, Personalized Drug Combinations  \nJason K. Sicklick, MD1,2,3  ; Daisuke Nishizaki, MD3,4  ; Hirotaka Miyashita, MD5  ; Ryosuke Okamura, MD6  ; Michael E. Hahn, MD7; Mina Nikanjam, MD, PhD3,4  ; Paul T. Fanta, MD3,4; David E. Piccioni, MD3,8; Hitendra Patel, MD3,4  ; Ramez N. Eskander, MD3,9  ;  \nRana R. McKay, MD3,4  ; Jeffrey S. Ross, MD10,11  ; J. Jack Lee, PhD, MS, DDS12  ; Scott M. Lippman, MD3,4  ; Shumei Kato, MD3,4  ; and Razelle Kurzrock, MD13   \nDOI [https://doi.org/10.1200/JCO-25-01453](https://doi.org/10.1200/JCO-25-01453)  \n\n| ABSTRACT |  |\n| --- | --- |\n| PURPOSE | Malignancies have complex and distinct molecular profiles that may not segregate by tumor type. However, most precision oncology treatments are matched to a single biomarker. We aimed to optimize therapy for advanced cancers using individually dosed drug regimens customized to cotarget multiple molecular alterations. |\n| METHODS | Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT; NCT02534675) is a prospective, investigator-initiated, multidepartment/pan-cancer trial for aggressive advanced/metastatic malignancies. Patients had tissue and/or blood next-generation sequencing (NGS; Foundation Medicine) . A molecular tumor board made suggestions. Degree of biomarker matching to drugs given was calculated by a matching score (MS; broadly, number of pathogenic alterations targeted divided by total pathogenic alterations) . |\n| RESULTS | Overall, 210 evaluable patients (n 5 456 consented) received ≥1 US Food and Drug Administration–approved drug (mostly off label) after NGS. Median number of pathogenic alterations/tumor was five (range, 0-20); approximately 95% of patients had unique molecular landscapes. Consistent with I-PREDICT’s objective to optimize/tailor treatment for each patient, we administered 157 different regimens (including 103 personalized combinations without established safety/dosing data) . For previously unstudied combinations, starting doses were reduced and titrated to tolerance (intrapatient dose-finding); only 6.5% experienced Grade 3/4 drug-related toxicities (v 15.5% of those receiving established regimens) . Higher disease control rate (stable disease ≥6 months/ objective response), and longer progression-free survival and overall survival correlated significantly/independently/linearly with greater degrees of drug matching to alterations (higher MS), but did not vary by drug number ordosages. |\n| CONCLUSION | The I-PREDICT strategy of maximizing personalized biomarker matching with individually dosed customized drug combinations enabled safe and active N-of- 1 matched treatment, including regimens previously unstudied in Phase I trials. I-PREDICT represents a blueprint for a new personalized precision oncology paradigm, which merits validation via additional prospective trials. |\n\nACCOMPANYING CONTENT  \n Editorial, p. 515  \n Data Sharing Statement  \n Data Supplement  Protocol  \nAccepted October 28, 2025 Published January 8, 2026  \nJ Clin Oncol 44:540-552 © 2026 by American Society of Clinical Oncology  \nView Online Article  \nCreative Commons Attribution Non-Commercial No Derivatives 4.0 License  \nINTRODUCTION  \nPersonalized oncology is defined as customizing treatments to individual patients. This is a natural extension of precision oncology, which is based upon molecular profiling to  \nprecisely identify pharmacologically tractable tumor alterations. Significant initial headway has been made in precision oncology by targeting specific molecular disease subsets (eg, ALK inhibitors for ALK fusion-positive lung cancer) .1 Notably, however, many molecular driver events  \n540 | Volume 44, [Issue 7 |](Issue 7 | ascopubs.org/journal/jco)[ ascopubs.org/journal/jco](Issue 7 | ascopubs.org/jour","cbCaiaqQArUL8srz","https://ap.wps.com/l/cbCaiaqQArUL8srz","pdf",1044441,14,"English","# Abstract\n## Purpose\n## Methods\n## Results\n## Conclusion\n# Context\n## Key Objective\n## Knowledge Generated\n## Relevance","[{\"question\":\"What problem does I-PREDICT address in precision oncology?\",\"answer\":\"Many cancers have molecular profiles that do not align neatly with a single tumor type, and most precision oncology treatments match only one biomarker. I-PREDICT aims to improve treatment by targeting multiple molecular alterations for each patient.\"},{\"question\":\"How were patients assigned to individualized treatments in the study?\",\"answer\":\"Patients underwent tissue and/or blood next-generation sequencing, and a molecular tumor board suggested regimens. A matching score quantified how well targeted alterations matched the administered drugs.\"},{\"question\":\"What relationships did the study find between matching and clinical outcomes?\",\"answer\":\"Higher degrees of drug matching to molecular alterations correlated with better disease control and longer progression-free and overall survival. These outcomes did not vary by the number of drugs or starting doses.\"}]","Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT) N-of-1 Precision Oncology Study - Molecular Profiling to Match Individually Dosed, Personalized Drug Combinations | PDF",1790055462,35]