Spots Global Cancer Trial Database for Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies

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Trial Identification

Brief Title: Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies

Official Title: A Phase II Trial of Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies

Study ID: NCT05719428

Conditions

Solid Organ Malignancies

Interventions

DRUID AI Program

Study Description

Brief Summary: DRUID is a treatment decision support tool combining predictive models and public databases related to multi-gene markers, drug response screens, gene essentiality and clinical status of drugs to provide drug recommendations personalized based on an input genomic profile. We hypothesize that DRUID analysis of patients' somatic mutational profile from NGS diagnostic platform can be used as a treatment decision support tool in patients with refractory cancer without targetable mutations.

Detailed Description: 2.1. Hypothesis We hypothesize that DRUID analysis of patients' somatic mutational profile from NGS diagnostic platform can be used as a treatment decision support tool in patients with refractory cancer without targetable mutations. Using algorithm selected treatment from a panel of 60 drugs we predict an objective response rate (ORR) of ≥ 25%. 2.2. Primary Objectives • To prospectively determine if DRUID selected therapy based on NGS diagnostic profile input can lead to objective responses in refractory solid organ malignancies. 2.3. Secondary Objectives * To assess clinical benefit rate (complete response, partial response and stable disease for ≥ 24 weeks) * To assess progression-free and overall survival of patients treated with DRUID-guided therapy