Observational studyJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026
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.
Observational study in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02534675 (An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Malignancies and Poor Prognosis), which is not on this map. Cited by 7 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Malignancies and Poor Prognosis
Who cites it
7 citing papers in PubMed.
- Personalized medicine, scientific revolution or self-serving illusion: viewpoint from EORTC-PAMM Group.ESMO open · 2026Review
- Claudin 18.2 Targeting: A Pan-Cancer Perspective.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- Interleukin-2 transcriptomic expression correlates with prolonged survival and with GNAS alterations in patients with advanced cancers.ESMO open · 2026Article
- Navigating Complexity in the Precision Oncology Clinic: Pharmacists' Central Role in Drug Selection, Acquisition, and Dosing in a Real-World Clinic.Journal of immunotherapy and precision oncology · 2026Article
- Further Promise and Potential for Precision Medicine in Oncology.Journal of medical Internet research · 2026Article
- Molecular Profiling for Precision Oncology: Moving Beyond Feasibility and Safety.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Off-target drug repurposing for rare and ultra-rare cancers: towards a scalable therapeutic framework.Frontiers in genetics · 2026Article
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
purposeMalignancies 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.
methodsInvestigation 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).
resultsOverall, 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 (
conclusionThe 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.
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