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

NCT05719428 | Recruiting Phase 2

• 1 other identifier: 2022/00653
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Organ Malignancies

Keywords

Next generation sequencing; DRUID

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Defined as patient exhibiting a best study response of complete or partial clinical response based on radiological imaging per RECIST 1.1 criteria.

  10 months

Secondary Outcomes (2)

• Clinical benefit

  10 months

• Progression free survival

  From enrolment till disease progression or date of death or final follow-up visit (1 year).

Study Arms (1)

DRUID

EXPERIMENTAL

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.

Other: DRUID AI Program

Interventions

DRUID AI Program OTHER

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.

DRUID

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• School of Computing, National University of Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Department of Hematology-Oncology, National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (8)

• Hickcox JP. Treatment of fractures with Hirschhorn compression plates. J Am Vet Med Assoc. 1970 Jan 15;156(2):187-96. No abstract available.

  PMID: 5461196 BACKGROUND

• Garraway LA, Verweij J, Ballman KV. Precision oncology: an overview. J Clin Oncol. 2013 May 20;31(15):1803-5. doi: 10.1200/JCO.2013.49.4799. Epub 2013 Apr 15. No abstract available.

  PMID: 23589545 BACKGROUND

• Clerch AR, Miale JB. A comparison of the Unitest system with three other methods for determining blood glucose. Am J Clin Pathol. 1971 Feb;55(2):159-62. doi: 10.1093/ajcp/55.2.159. No abstract available.

  PMID: 5541669 BACKGROUND

• Mariappan R, Jayagopal A, Sien HZ, Rajan V. Neural Collective Matrix Factorization for integrated analysis of heterogeneous biomedical data. Bioinformatics. 2022 Sep 30;38(19):4554-4561. doi: 10.1093/bioinformatics/btac543.

  PMID: 35929808 BACKGROUND

• Nguyen T, Nguyen GTT, Nguyen T, Le DH. Graph Convolutional Networks for Drug Response Prediction. IEEE/ACM Trans Comput Biol Bioinform. 2022 Jan-Feb;19(1):146-154. doi: 10.1109/TCBB.2021.3060430. Epub 2022 Feb 3.

  PMID: 33606633 BACKGROUND

• Garnett MJ, Edelman EJ, Heidorn SJ, Greenman CD, Dastur A, Lau KW, Greninger P, Thompson IR, Luo X, Soares J, Liu Q, Iorio F, Surdez D, Chen L, Milano RJ, Bignell GR, Tam AT, Davies H, Stevenson JA, Barthorpe S, Lutz SR, Kogera F, Lawrence K, McLaren-Douglas A, Mitropoulos X, Mironenko T, Thi H, Richardson L, Zhou W, Jewitt F, Zhang T, O'Brien P, Boisvert JL, Price S, Hur W, Yang W, Deng X, Butler A, Choi HG, Chang JW, Baselga J, Stamenkovic I, Engelman JA, Sharma SV, Delattre O, Saez-Rodriguez J, Gray NS, Settleman J, Futreal PA, Haber DA, Stratton MR, Ramaswamy S, McDermott U, Benes CH. Systematic identification of genomic markers of drug sensitivity in cancer cells. Nature. 2012 Mar 28;483(7391):570-5. doi: 10.1038/nature11005.

  PMID: 22460902 BACKGROUND

• De Lange T, Kooter JM, Michels PA, Borst P. Telomere conversion in trypanosomes. Nucleic Acids Res. 1983 Dec 10;11(23):8149-65. doi: 10.1093/nar/11.23.8149.

  PMID: 6324075 BACKGROUND

• Ford TF, Grant DA, Austen BM, Hermon-Taylor J. Intramucosal activation of pepsinogens in the pathogenesis of acute gastric erosions and their prevention by the potent semisynthetic amphipathic inhibitor pepstatinyl-glycyl-lysyl-lysine. Clin Chim Acta. 1985 Jan 15;145(1):37-47. doi: 10.1016/0009-8981(85)90017-8.

  PMID: 3919969 BACKGROUND

Study Officials

• Robert John Walsh

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert John Walsh

CONTACT

69082222; robert_walsh@nuhs.edu.sg

Robert John Walsh

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 9, 2023
• Study Start: August 28, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)