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.

DRUID AI Program

Robert John Walsh

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.

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

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.

Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies

A Phase II Trial of Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies

Defined as patient exhibiting a best study response of complete or partial clinical response based on radiological imaging per RECIST 1.1 criteria.

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).

Defined as the time from the date of study enrolment to the first date of documented disease progression.

School of Computing, National University of Singapore

Cancer Science Institute, National University of Singapore

National University Hospital, Singapore

a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A(TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)

a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A (TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)

NOV1601(CHC2014)

Dong-Wan Kim, MD, PhD

Tak Yun, MD, PhD

Sang-Joon Shin, MD, PhD

Yong-Wha Moon, MD, PhD

This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.

This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.

Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).

A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).

Each adverse event will be coded using the Medical Dictionary for Regulatory Activities(version 20.0) classification system. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies	NCT05719428	Solid Organ Mal...	DRUID AI Progra...	21 Years - 99 Years	National University Hospital, Singapore
Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies	NCT05719428	Solid Organ Mal...	DRUID AI Progra...	21 Years - 99 Years	National University Hospital, Singapore
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies	NCT04014257	Phase 1 Solid Tumor, Ad...	NOV1601(CHC2014...	19 Years -	Handok Inc.
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies	NCT04014257	Phase 1 Solid Tumor, Ad...	NOV1601(CHC2014...	19 Years -	Handok Inc.

Spots Global Cancer Trial Database for solid organ malignancies