2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T766,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. 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). Overall, 210 evaluable patients (n = 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 ( 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.31:Tc7c, 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. 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). RESULTS Overall, 210 evaluable patients (n = 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 or dosages. 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. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Single-Arm Interventional Trial: study design Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Single-Arm Interventional Trial (study design). Clinician-written summaries and actionable practice insights. 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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 (","abstract":"$30","keywords":[],"pubmed_id":"41505666","conclusions":"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.","publication_date":"2026-01-08T00:00:00"},"crossref":{"DOI":"10.1200/jco-25-01453","URL":"https://doi.org/10.1200/jco-25-01453","ISSN":["0732-183X","1527-7755"],"link":[{"URL":"https://ascopubs.org/doi/pdfdirect/10.1200/JCO-25-01453","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["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"],"author":[{"given":"Jason K.","family":"Sicklick","sequence":"first","affiliation":[{"name":"Division of Surgical Oncology, Department of Surgery, UC San Diego, San Diego, CA"},{"name":"Department of Pharmacology, UC San Diego, San Diego, CA"},{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"}]},{"given":"Daisuke","family":"Nishizaki","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Hematology Oncology, Department of Medicine, UC San Diego School of Medicine, San Diego, CA"}]},{"given":"Hirotaka","family":"Miyashita","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Dartmouth Cancer Center, Lebanon, NH"}]},{"given":"Ryosuke","family":"Okamura","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kyoto University Hospital, Kyoto, Japan"}]},{"given":"Michael E.","family":"Hahn","sequence":"additional","affiliation":[{"name":"Department of Radiology, UC San Diego, San Diego, CA"}]},{"given":"Mina","family":"Nikanjam","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Hematology Oncology, Department of Medicine, UC San Diego School of Medicine, San Diego, CA"}]},{"given":"Paul T.","family":"Fanta","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Hematology Oncology, Department of Medicine, UC San Diego School of Medicine, San Diego, CA"}]},{"given":"David E.","family":"Piccioni","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Neuro-oncology, Department of Neurosciences, UC San Diego, San Diego, CA"}]},{"given":"Hitendra","family":"Patel","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Hematology Oncology, Department of Medicine, UC San Diego School of Medicine, San Diego, CA"}]},{"given":"Ramez N.","family":"Eskander","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego, San Diego, CA"}]},{"given":"Rana R.","family":"McKay","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, UC San Diego, La Jolla, CA"},{"name":"Division of Hematology Oncology, Department of Medicine, UC San Diego School of Medicine, San Diego, CA"}]},{"given":"Jeffrey S.","family":"Ross","sequence":"additional","affiliation":[{"name":"Foundation Medicine, Inc, Cambridge, MA"},{"name":"Departments of Pathology, Medicine (Oncology) and Urology, SUNY Upstate Medical University, Syracuse, NY"}]},{"given":"J. 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