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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

October 4, 2026

Study Completion Date

April 4, 2027

Conditions
Solid TumorGastrointestinal CancerBreast Cancer
Interventions
DEVICE

QPOP

QPOP is a mechanism-agnostic platform for optimizing drug selection. QPOP uses a quadratic equation to describe the patient-specific drug-drug interaction space based solely on experimentally derived drug-response data on individual patient's tissue sample, from which optimal drug combinations can be identified. Drug selection via QPOP allows for identification of an optimal combination therapy without the need for exhaustive testing of every combination. The first stage of the trial aims to generate a personalised QPOP drugs list for each participant based on experimentally derived data from ex vivo testing in the participant's tissue sample. Optimal drugs from a pre-specified drug pool will be recommended by the QPOP team.

DEVICE

CURATE.AI

"CURATE.AI - a small data, AI-derived technology platform based on this discovery - allows personalised guidance of an individual's dose modulations based only on that individual's data. Additionally, CURATE.AI is mechanism-independent, and dynamically adapts to changes experienced by the participant, providing dynamic dose optimisation throughout the duration of the participant's treatment.~The second stage of the trial aims to obtain a personalised CURATE.AI profile for each participant, based on their phenotypic response to a set of drug doses from the drug combinations with azacitidine identified and recommended by the QPOP team. The doses will be recommended by the CURATE.AI team, when relevant to the clinical decision-making process. Once an actionable profile is obtained, dose recommendations are based on the profile and aimed to treat the participant.~The maximum period of involvement with this study when azacitidine may be adjusted by CURATE.AI is 18 months."

DRUG

Azacitidine + docetaxel

"Azacitidine subcutaneous injection Day 1, 2 and Day 8, 9 + 30 mg/m2 docetaxel intravenously Day 1 and 8~Each chemotherapy cycle will be 21 days."

DRUG

Azacitidine + paclitaxel

"Azacitidine subcutaneous injection Day 1, 2 and Day 8, 9 + 80 mg/m2 paclitaxel intravenously Day 1 and 8~Each chemotherapy cycle will be 21 days."

DRUG

Azacitidine + irinotecan

"Azacitidine intravenously subcutaneous injection Day 1, 2 and Day 8, 9 + 100 mg/m2 irinotecan intravenously Day 1 and 8.~Each chemotherapy cycle will be 21 days."

Trial Locations (1)

119074

RECRUITING

National University Hospital, Singapore

All Listed Sponsors
collaborator

The N.1 Institute for Health (N.1)

OTHER

collaborator

Cancer Science Institute of Singapore

UNKNOWN

lead

National University Hospital, Singapore

OTHER