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NCT05381038
Optimizing and Personalising Azacitidine Combination Therapy for Treating Solid Tumours QPOP and CURATE.AI
Phase 1, PHASE2 trial testing QPOP in Solid Tumor in 10 participants. Currently enrolling.
4 October 2026
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 13 February 2023 |
| Primary completion | 4 October 2026 |
| Estimated completion | 4 April 2027 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- QPOP
- CURATE.AI
- Azacitidine + docetaxel — full drug profile →
- Azacitidine + paclitaxel — full drug profile →
- Azacitidine + irinotecan — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
- Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →
- Breast Cancer — all drugs for Breast Cancer →
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):
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Human disease models in drug development.
Loewa A, Feng JJ, Hedtrich S. · · 2023 · cited 164× · PMID 37359774 · DOI 10.1038/s44222-023-00063-3 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05381038
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of QPOP
Trials testing the same drug.
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Other National University Hospital, Singapore trials
Trials by the same sponsor.
- NCT06027983 — Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05381038 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University Hospital, Singapore
- Last refreshed: 23 September 2025
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