Actively Recruiting
Optimizing and Personalising Azacitidine Combination Therapy for Treating Solid Tumours QPOP and CURATE.AI
Led by National University Hospital, Singapore · Updated on 2025-09-23
10
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
T
The N.1 Institute for Health (N.1)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing and Personalising Azacitidine Combination Therapy for Treating Solid Tumours QPOP and CURATE.AI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 21 years of age or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Absolute neutrophil count (ANC) 1000/mm3 or higher and platelet count 50,000/mm3 or higher within 21 days of treatment start
- Total bilirubin no more than 1.5 times the upper limit of normal (ULN); ALT and AST no more than 3 times ULN or no more than 5 times ULN if liver involved
- Creatinine clearance 30 mL/min or higher or creatinine less than 1.5 times ULN within 21 days of treatment start
- Diagnosed with breast or gastric cancer where docetaxel, paclitaxel, or irinotecan is indicated for palliative therapy
- Previously underwent QPOP drug screening indicating potential benefit from combining azacitidine with taxane or irinotecan
- Raised response markers above normal limits such as CEA, CA19-9, CA 15-3, CA 125, AFP, or methylation markers like DNMT
You will not qualify if you...
- Lactating or pregnant patients
- Clinically significant hypersensitivity to any drug in the selected regimen
- Contraindications to any required concomitant drugs or supportive treatments
- Medical or psychiatric conditions that may interfere with study adherence or informed consent
- Major surgery within 28 days before starting treatment
- Active congestive heart failure (NYHA Class III or IV), symptomatic ischaemia, uncontrolled conduction abnormalities, or recent myocardial infarction within 4 months
- Previous chemotherapy with docetaxel, paclitaxel, or irinotecan allowed only with approval if enrolling for treatment with the same drug plus azacitidine
- Clinical suspicion or diagnosis of Gilbert's syndrome excludes enrollment for azacitidine plus irinotecan but may allow enrollment for azacitidine plus docetaxel or paclitaxel if other criteria are met
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
Research Team
W
Wei Peng Yong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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