AI tool for personalized treatment in patients with advanced solid tumors
A Phase II Trial of Neural Network-based Treatment Decision Support Tool in Patients With Refractory Solid Organ Malignancies
This study is testing a new tool that uses genetic information to suggest personalized treatments for patients with advanced solid tumors who have already tried several therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05719428 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the DRUID treatment decision support tool, which utilizes predictive models and public databases to recommend personalized drug therapies based on patients' genomic profiles. The study focuses on patients with refractory solid organ malignancies who lack targetable mutations and have previously undergone multiple lines of therapy. By analyzing somatic mutational profiles from next-generation sequencing (NGS), the trial aims to determine if DRUID-guided therapy can lead to objective responses and improve clinical outcomes. The primary objective is to assess the objective response rate, while secondary objectives include evaluating clinical benefit rates and survival outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with refractory solid organ malignancies and available NGS testing results.
Not a fit: Patients who have not received prior systemic therapy or those with non-solid organ malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide personalized treatment options for patients with advanced cancers that currently have limited therapeutic options.
How similar studies have performed: Other studies utilizing genomic profiling and AI-driven treatment recommendations have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
Patients may be included in the study only if they meet all of the following criteria:
* Age ≥ 21 years.
* Histological or cytological diagnosis solid organ malignancy
* Available results of comprehensive NGS panel testing performed on either tumour tissue or blood-based assay. If results are from blood-based assay, test must have been performed in the metastatic setting.
* ECOG 0-2.
* At least 1 measurable tumour lesions based on RECIST 1.1 criteria
* Estimated life expectancy of at least 12 weeks.
* Has documented progressive disease from last line of therapy.
* Has received at least 2 lines of palliative systemic therapy with no available standard therapy:
* Adequate organ function including the following:
* Bone marrow:
* Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L
* Haemoglobin ≥ 8 x 109/L
* Hepatic:
* Bilirubin ≤ 1.5 x upper limit of normal (ULN),
* ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases)
* Renal:
* Creatinine ≤ 1.5x ULN
* Signed informed consent from patient or legal representative.
* Able to comply with study-related procedures.
Exclusion Criteria:
* Treatment within the last 30 days with any investigational drug.
* Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Major surgery within 28 days of study drug administration.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Active bleeding disorder or bleeding site.
* Non-healing wound.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.
* Symptomatic brain metastasis.
Where this trial is running
Singapore
- Department of Hematology-Oncology, National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Robert John Walsh — National University Hospital, Singapore
- Study coordinator: Robert John Walsh
- Email: robert_walsh@nuhs.edu.sg
- Phone: 69082222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.