What this study is
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.
What's being tested
- Darwin OncoTarget and OncoTreat
Intervention · 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.
Study details
- Official title
- Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing to Improve Outcomes for Patients With Limited Metastatic Disease That Failed First-Line Systemic Therapy
- Sponsor
- Good Samaritan Hospital Medical Center, New York
- Conditions
- Personalized Medicine · Oligometastatic Disease · Feasibility
- Enrolling
- 20 people
- Starts
- 2025-03-10
- Est. completion
- 2027-04-10
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openGood Samaritan University Hospital
West Islip, New York, United States
- Lara Rush · Contact631-376-3093LaraR.Rush@chsli.org
- Johnny Kao, MD · Principal investigator
Study team
Sponsor
Good Samaritan Hospital Medical Center, New York
Study ID 24-002
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.