On September 29, 2025, a new clinical trial emerged with promising implications for those in oncology and medical device regulation: the pilot study exploring an implantable microdevice for in situ drug testing in patients with colorectal liver metastases. Sponsored by Northwell Health, the trial features cancer therapeutics such as Doxorubicin, Bevacizumab, and new investigational compounds, aiming to optimize personalized treatment. Although recruitment has not yet begun, medical and regulatory professionals should closely monitor developments in device-based drug responsiveness.
What is the implantable microdevice for drug response evaluation?
The trial revolves around a novel implantable microdevice designed to test multiple drugs directly within tissue affected by colorectal liver metastases. By embedding the device locally during a minimally invasive procedure, researchers aim to measure how specific therapeutics interact with the tumor microenvironment. This innovation could significantly enhance drug selection, streamlining personalized cancer treatment strategies.
Which therapeutics are targeted?
A wide range of therapies, both established and investigational, are included:
- Doxorubicin – A widely used chemotherapeutic agent.
- FOLFOX, FOLFIRI, FOLFIRINOX – Standard chemotherapy regimens for colorectal cancer.
- Bevacizumab – A monoclonal antibody targeting vascular endothelial growth factor (VEGF).
- Botensilimab and Balstilimab – Immunotherapies under study.
- AGEN2373 – An experimental therapy with promising preliminary data.
This combination of treatments addresses tumor growth pathways, immune modulation, and vascular support around the metastatic tumors.
What is the current status of the study?
According to clinicaltrials.gov, the study is categorized as “not yet recruiting.” Physicians, oncology specialists, and medical device regulatory teams should remain informed about enrollment initiation, expected to reveal crucial viability data for this groundbreaking drug-testing device.
FAQ
- What makes this device different?
The microdevice allows localized testing of therapeutics directly in tumor tissues, eliminating reliance on generalized systemic trials alone. - Who is eligible for enrollment?
Patients diagnosed with colorectal liver metastases may qualify. Enrollment details will clarify the inclusion/exclusion criteria. - Are these therapies FDA-approved?
Some targeted therapies, like FOLFOX and Bevacizumab, are FDA-approved, while others, such as AGEN2373, are investigational.
Key takeaways
The pilot study sponsored by Northwell Health offers distinct potential in medical oncology by advancing the assessment of drug response through a cutting-edge microdevice. Regulatory teams should anticipate vital data on device safety, performance, and therapeutic synergy insights in metastatic colorectal cancer treatment.
Disclaimer
This article provides factual information sourced from clinicaltrials.gov and is intended for professional audiences. It does not constitute legal or regulatory advice.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07193862?term=medical+device