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NCT05381038

Optimizing and Personalising Azacitidine Combination Therapy for Treating Solid Tumours QPOP and CURATE.AI

Recruiting now Phase 1, PHASE2 Last updated 23 September 2025
What this trial tests

Phase 1, PHASE2 trial testing QPOP in Solid Tumor in 10 participants. Currently enrolling.

Timeline
13 February 2023
Primary endpoint
4 October 2026
4 April 2027

Quick facts

Lead sponsorNational University Hospital, Singapore
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment10
Start date13 February 2023
Primary completion4 October 2026
Estimated completion4 April 2027
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

National University Hospital, Singapore

Who can join

Adults 21 to 99, any sex, with Solid Tumor or Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot feasibility study aims to set the foundation to investigate the applicability of QPOP drug selection followed by CURATE.AI-guided dose optimisation of the selected azacitidine combination therapy for solid tumours using CURATE.AI within the current clinical setting. QPOP will identify drug interactions towards optimal efficacy and cytotoxicity from the pre-specified drug pool based on ex vivo experimental data from the individual participant's tissue sample model. With these drug interactions, QPOP will identify the optimal drugs for the specific participant whose biopsy provided the cells for the ex vivo experimentation. Subsequently, CURATE.AI will be used to guide dosing for the selected combination therapy for that participant. Individualised CURATE.AI profiles will be generated based on each participant's response to a set of drug doses. Subsequently, the personalised CURATE.AI profile will be used to recommend the efficacy-driven dose. CURATE.AI will operate only within the safety range for each drug pre-specified for each participant. This pilot feasibility study will inform the investigators on the logistical and scientific feasibility of performing a large-scale randomised controlled trial (RCT) with the selected azacitidine combination therapy regimens and response markers. A secondary objective is to collect toxicity and efficacy data using established and exploratory response markers within and in-between cycles as exploratory outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Human disease models in drug development.
    Loewa A, Feng JJ, Hedtrich S. · · 2023 · cited 164× · PMID 37359774 · DOI 10.1038/s44222-023-00063-3
  2. Tribulations and future opportunities for artificial intelligence in precision medicine.
    Carini C, Seyhan AA. · · 2024 · cited 67× · PMID 38702711 · DOI 10.1186/s12967-024-05067-0
  3. Predictive Biomarkers of Response to Neoadjuvant Chemotherapy in Breast Cancer: Current and Future Perspectives for Precision Medicine.
    Derouane F, van Marcke C, Berlière M, Gerday A, et al · · 2022 · cited 54× · PMID 36010869 · DOI 10.3390/cancers14163876
  4. Epigenetic modulation of antitumor immunity and immunotherapy response in breast cancer: biological mechanisms and clinical implications.
    Yin J, Gu T, Chaudhry N, Davidson NE, et al · · 2023 · cited 25× · PMID 38268926 · DOI 10.3389/fimmu.2023.1325615
  5. N-of-1 medicine.
    Wang P, Leong QY, Lau NY, Ng WY, et al · · 2024 · cited 5× · PMID 38527301 · DOI 10.4103/singaporemedj.smj-2023-243
  6. Comparative epigenomics to clinical trials in human breast cancer and canine mammary tumor.
    Jeong SJ, Lee KH, Cho JY. · · 2025 · cited 3× · PMID 40115961 · DOI 10.1080/19768354.2025.2477024
  7. Combination of Genomic Landsscape and 3D Culture Functional Assays Bridges Sarcoma Phenotype to Target and Immunotherapy.
    de Nigris F, Meo C, Palinski W. · · 2023 · cited 3× · PMID 37681936 · DOI 10.3390/cells12172204
  8. Patient-Derived Ex Vivo Cultures and Endpoint Assays with Surrogate Biomarkers in Functional Testing for Prediction of Therapeutic Response.
    Tsukamoto Y, Hirashita Y, Shibata T, Fumoto S, et al · · 2023 · cited 3× · PMID 37627132 · DOI 10.3390/cancers15164104

Verify or expand the search:

Other trials of QPOP

Trials testing the same drug.

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

Other National University Hospital, Singapore trials

Trials by the same sponsor.

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