AI tool for personalized treatment in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.