NCT05719428

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Organ Malignancies

Interventions

Type	Name	Description
OTHER	DRUID AI Program	Patients will begin single agent therapy within 4 weeks of enrolment and continue until disease progression, maximum safe cumulative dose reached (where applicable, per standard institution practice) or unacceptable toxicity as per physician's discretion.

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2023-02-09
• Last updated: 2025-07-25

Locations

1 site across 1 country: Singapore