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

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

NCT ID: NCT05719428

Condition: Solid Organ Malignancies

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Next generation sequencing
DRUID

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Patients NGS profile will be analysed with DRUID system to generate recommendations based on predicted efficacy. Patients with available archival tissue will have gene expression analysis performed to optimise DRUID recommendation. Patients will subsequently receive single agent therapy based on DRUID recommendations and criteria for therapy choice. 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.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: DRUID AI Program
Description: 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.
Arm group label: DRUID

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: - Age ≥ 21 years. - Histological or cytological diagnosis solid organ malignancy - Available results of comprehensive NGS panel testing performed on either tumour tissue or blood-based assay. If results are from blood-based assay, test must have been performed in the metastatic setting. - ECOG 0-2. - At least 1 measurable tumour lesions based on RECIST 1.1 criteria - Estimated life expectancy of at least 12 weeks. - Has documented progressive disease from last line of therapy. - Has received at least 2 lines of palliative systemic therapy with no available standard therapy: - Adequate organ function including the following: - Bone marrow: - Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 100 x 109/L - Haemoglobin ≥ 8 x 109/L - Hepatic: - Bilirubin ≤ 1.5 x upper limit of normal (ULN), - ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases) - Renal: - Creatinine ≤ 1.5x ULN - Signed informed consent from patient or legal representative. - Able to comply with study-related procedures. Exclusion Criteria: - Treatment within the last 30 days with any investigational drug. - Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. - Major surgery within 28 days of study drug administration. - Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. - Pregnancy. - Breast feeding. - Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. - Active bleeding disorder or bleeding site. - Non-healing wound. - Second primary malignancy that is clinically detectable at the time of consideration for study enrolment. - Symptomatic brain metastasis.

Gender: All

Minimum age: 21 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Hematology-Oncology, National University Hospital

Address:
City: Singapore
Zip: 119074
Country: Singapore

Status: Recruiting

Start date: August 28, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: National University Hospital, Singapore
Agency class: Other

Collaborator:
Agency: School of Computing, National University of Singapore
Agency class: Other

Collaborator:
Agency: Cancer Science Institute, National University of Singapore
Agency class: Other

Source: National University Hospital, Singapore

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05719428