Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing

NCT06842030 | Not Yet Recruiting

• 1 other identifier: 24-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.

Conditions

Personalized Medicine; Oligometastatic Disease; Feasibility

Outcome Measures

Primary Outcomes (4)

• Feasibility: Test Performance Ability To Perform Test Versus Unable to Perform Test with Pathology Samples Needed >50% Tumor Tissue

  Proportion of participants whose tumor biopsy successfully undergoes OncoTarget and OncoTreat testing based on sufficient cellularity/DNA/RNA, defined as \>50% tumor.

  Through study completion, an average of 2 years

• Feasibility: Percent Medication Change Versus No Medication Change Based on Treating Medical Oncologist Decision

  Percentage of participants whose chemotherapy management plan is changed based on the willingness of the medical oncologist to try at least one off-label medication recommended by Darwin testing.

  Through study completion, an average of 2 years

• Feasibility: Percent Medication Procured Through Insurance and/or Compassionate Use Versus Unable to Attain

  Out of the participants who are prescribed a drug from Darwin testing, the percentage that are procured FDA approved on-label and/or off-label agents through insurance or compassionate use in the setting of extensive preauthorization requirements prevalent in community oncology practice.

  Through study completion, an average of 2 years

• Feasibility: Qualitative Measurement of Barriers Noted Throughout Study

  Quantification and explanation of any unknown barriers that occur throughout the study process preventing an eligible participant from starting a drug recommended by Darwin testing.

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Systemic Therapy Change Compared to Standard of Care

  Through study completion, an average of 2 years

• Progression-Free Survival

  Patients will be followed as per standard of care, up to 5 years or until death. Event determined from date of enrollment until first documented progression or death from any cause, whichever came first, assessed up to 5 years.

Study Arms (1)

Feasibility

EXPERIMENTAL

All study participants will get the same study intervention. It will include the usual radiation to all areas of visible disease. Systemic therapy will be determined by your medical oncologist with the supplemental information provided by the Darwin OncoTarget and OncoTreat test.

Diagnostic Test: Darwin OncoTarget and OncoTreat

Interventions

Darwin OncoTarget and OncoTreat DIAGNOSTIC_TEST

Darwin OncoTarget and OncoTreat predict potential drugs with early markers of efficacy in early human clinical trials. Specifically, OncoTarget identifies high-affinity inhibitors of master regulator proteins, while OncoTreat identifies tumor-checkpoint module inhibitors that modulate the transcriptional activity of hyper-connected master regulators. These tests are now commercially available with Clinical Laboratory Improvement Amendments (CLIA) approval through Columbia Presbyterian Medical Center.

Feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age ≥18 years with metastatic solid tumor who are candidates for comprehensive involved site radiotherapy to all areas of disease seen on whole body imaging.
• Patients with brain metastases are eligible provided they qualify as oligometastases (up to 10 lesions based on the SABR-COMET-10 trial) and are treatable with radiotherapy to all areas of visible disease.
• Patients with adequate bone marrow (absolute neutrophil ≥1000, hemoglobin ≥ 9 g/dl, platelets ≥100,000), kidney (creatinine ≤1.5 times upper limit of normal) and liver (bilirubin ≤1.5 times upper limit of normal).
• Patients being treated by radiation oncology at Good Samaritan University Hospital.

You may not qualify if:

• Patients with an estimated median survival of less than 6 months using the published and validated NEAT methodology.
• Patients who are pregnant and/or breast feeding or those with severe uncontrolled cardiac, pulmonary, infectious or organic brain disease.

Sponsors & Collaborators

• Good Samaritan Hospital Medical Center, New York: lead

Study Sites (1)

Good Samaritan University Hospital

West Islip, New York, 11795, United States

Location

Related Publications (25)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility of n=20

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 24, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)