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RecruitingNCT05719428DRUIDUpdated Jul 25, 2025

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

A Phase 2 interventional study of DRUID AI Program in Solid Organ Malignancies, sponsored by National University Hospital, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
21 Years to 99 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Solid Organ Malignancies

Keywords

  • Next generation sequencing
  • DRUID
03

In context

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • Experimental
    DRUID

    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

  • OtherDRUID 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.

06

What researchers measure

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.

    Time frame: 10 months

Secondary outcomes

  1. Clinical benefit

    Defined as presence of best study response of complete or partial response or stable disease for at least 24 weeks (based on RECIST 1.1 criteria).

    Time frame: 10 months

  2. Progression free survival

    Defined as the time from the date of study enrolment to the first date of documented disease progression.

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

07

Study locations

1 of 1 sites recruiting
  • Department of Hematology-Oncology, National University Hospital
    Singapore, 119074, Singapore
    Recruiting
08

References and documents

Publications

  • Zehir A, Benayed R, Shah RH, Syed A, Middha S, Kim HR, Srinivasan P, Gao J, Chakravarty D, Devlin SM, Hellmann MD, Barron DA, Schram AM, Hameed M, Dogan S, Ross DS, Hechtman JF, DeLair DF, Yao J, Mandelker DL, Cheng DT, Chandramohan R, Mohanty AS, Ptashkin RN, Jayakumaran G, Prasad M, Syed MH, Rema AB, Liu ZY, Nafa K, Borsu L, Sadowska J, Casanova J, Bacares R, Kiecka IJ, Razumova A, Son JB, Stewart L, Baldi T, Mullaney KA, Al-Ahmadie H, Vakiani E, Abeshouse AA, Penson AV, Jonsson P, Camacho N, Chang MT, Won HH, Gross BE, Kundra R, Heins ZJ, Chen HW, Phillips S, Zhang H, Wang J, Ochoa A, Wills J, Eubank M, Thomas SB, Gardos SM, Reales DN, Galle J, Durany R, Cambria R, Abida W, Cercek A, Feldman DR, Gounder MM, Hakimi AA, Harding JJ, Iyer G, Janjigian YY, Jordan EJ, Kelly CM, Lowery MA, Morris LGT, Omuro AM, Raj N, Razavi P, Shoushtari AN, Shukla N, Soumerai TE, Varghese AM, Yaeger R, Coleman J, Bochner B, Riely GJ, Saltz LB, Scher HI, Sabbatini PJ, Robson ME, Klimstra DS, Taylor BS, Baselga J, Schultz N, Hyman DM, Arcila ME, Solit DB, Ladanyi M, Berger MF. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nat Med. 2017 Jun;23(6):703-713. doi: 10.1038/nm.4333. Epub 2017 May 8. PubMed 28481359 ↗
  • 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. PubMed 23589545 ↗
  • Califano A, Alvarez MJ. The recurrent architecture of tumour initiation, progression and drug sensitivity. Nat Rev Cancer. 2017 Feb;17(2):116-130. doi: 10.1038/nrc.2016.124. Epub 2016 Dec 15. PubMed 27977008 ↗
  • 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. PubMed 35929808 ↗
  • 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. PubMed 33606633 ↗
  • 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. PubMed 22460902 ↗
  • Kim S, Chen J, Cheng T, Gindulyte A, He J, He S, Li Q, Shoemaker BA, Thiessen PA, Yu B, Zaslavsky L, Zhang J, Bolton EE. PubChem 2019 update: improved access to chemical data. Nucleic Acids Res. 2019 Jan 8;47(D1):D1102-D1109. doi: 10.1093/nar/gky1033. PubMed 30371825 ↗
  • Cancer Genome Atlas Research Network; Weinstein JN, Collisson EA, Mills GB, Shaw KR, Ozenberger BA, Ellrott K, Shmulevich I, Sander C, Stuart JM. The Cancer Genome Atlas Pan-Cancer analysis project. Nat Genet. 2013 Oct;45(10):1113-20. doi: 10.1038/ng.2764. PubMed 24071849 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05719428
Lead sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
Responsible party
Sponsor
First posted
Feb 9, 2023
Start date
Aug 28, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jul 25, 2025

Study contacts

Robert John Walsh
Contact
robert_walsh@nuhs.edu.sg
69082222
Robert John Walsh
Contact
Robert John Walsh
principal investigator · National University Hospital, Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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