Solid Organ MalignanciesPhase 2DRUIDNCT05719428
Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies
A Phase 2 study testing DRUID AI Program in people with Solid Organ Malignancies, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Solid Organ Malignancies
- What is being tested?
- DRUID AI Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Aug 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert John Walsh contact
Singapore1 site, 1 recruiting
- Recruiting
Department of Hematology-Oncology, National University Hospital
Singapore, 119074
About this study
Official title: A Phase II Trial of Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies
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
- Conditions
- Solid Organ Malignancies
- Being tested
- DRUID AI Program
- Keywords
- Next generation sequencing, DRUID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRUID AI ProgramOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: DRUID AI Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Secondary outcomes (2)
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).
Measured: 10 months
Progression free survival
Defined as the time from the date of study enrolment to the first date of documented disease progression.
Measured: From enrolment till disease progression or date of death or final follow-up visit (1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start28 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Solid Organ MalignanciesStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Robert John Walsh, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719428
- Sponsor's protocol ID
- 2022/00653
- Acronym
- DRUID
- Status last verified
- Jul 2025
- First submitted
- 30 Jan 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28481359Garraway 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 23589545Califano 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 27977008Mariappan 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 35929808Nguyen 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 33606633Garnett 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 22460902Kim 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 30371825Cancer 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies
- ClinicalTrials.gov ID
- NCT05719428
- Acronym / sponsor ID
- DRUID / 2022/00653
- Conditions
- Solid Organ Malignancies
- Keywords
- Next generation sequencing, DRUID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| DRUID | Experimental | Other: DRUID AI ProgramPatients 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRUID AI ProgramPatients 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. | Other | DRUID |
Primary outcome
Objective response rate (ORR)
Time frame: 10 months
Defined as patient exhibiting a best study response of complete or partial clinical response based on radiological imaging per RECIST 1.1 criteria.
2 secondary outcomes
Clinical benefit
Time frame: 10 months
Progression free survival
Time frame: From enrolment till disease progression or date of death or final follow-up visit (1 year).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 28481359Zehir 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.
- Background: PubMed 23589545Garraway 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.
- Background: PubMed 27977008Califano 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.
- Background: PubMed 35929808Mariappan 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.
- Background: PubMed 33606633Nguyen 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.
- Background: PubMed 22460902Garnett 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.
- Background: PubMed 30371825Kim 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.
- Background: PubMed 24071849Cancer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert John Walsh contact
Robert John Walsh principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DRUID AI Program in people with Solid Organ Malignancies, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert John Walsh (69082222, robert_walsh@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719428, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025; AzTrials last refreshed its copy on 4 Nov 2026.