# Clinical Evaluation of an Implantable Lab-in-a-patient microdevice that measures in-situ response to therapies in advanced ovarian cancer

> **NIH NIH R21** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $215,172

## Abstract

Project summary:
 Ovarian cancer (OC) is a leading cause of cancer deaths in women in the United States. The clinical
treatment of OC is marked by high initial response rates to 1st line standard-of-care (SOC) platinum/taxane
treatment, but also significant relapse rates. A major unmeet need in this disease exists to identify optimal
2nd line therapy options in the platinum resistant or refractory setting which yield superior outcomes
compared with current treatment selection which is largely empirical.
 Many single and combination agents are currently in use or in clinical trials as 2nd line treatments
for OC, but there are few reliable biomarkers available to predict response to these various types of
cytotoxic or targeted chemotherapies. Recent studies have identified potential genomic and other markers,
including BRCA1/2, VEGF, MAPK, PI3K and others. Advances in biomarker identification, however, are
slow because each trial only administers a single therapy on every patient at a given time, and thus only
allows biomarker/phenotype correlations on one therapy at a given tumor state.
We have developed a technology that allows us to measure the phenotypic effect of a large number of
distinct agents or drug combinations within a single tumor in a rapid and minimally invasive manner and
without systemic toxicities. The technology represents a new paradigm for predicting proactively, rather
than empirically, the effect of drugs inside a patient tumor. Consisting of implantable microdevices, which
release microdoses of up to 120 distinct agents or combinations in parallel into small confined regions of
tumor, it allows for direct measurement of drug/tumor interaction using established pharmacodynamic
readouts for each therapy tested within the native tumor microenvironment.
 This proposal seeks to translate the microdevices into clinical use through a pilot trial in ovarian
cancer patients. Up to 6 microdevices will be implanted into omental tumors one day prior to surgery where
they are expected to provide a rapid and comprehensive snapshot of how the tumor actually responds to all
the available therapies. 6 spatially separated readouts from distinct parts of the tumor will also provide a
novel functional examination of tumor heterogeneity. All of the readouts will be correlated with genomic,
transcriptomic, immune and tissue biomarkers, effectively performing 20 or more biomarker trials in each
patient with six-fold replicates, with only one extra biopsy procedure, and at minute drug exposure levels.
 This unprecedented clinical study seeks to validate safety, usage and procedures for obtaining
multiple drug phenotypes from microdevices within patients, and to significantly expand the field's
understanding of predictive biomarkers in ovarian cancer. If successful, this research may lay the foundation
for application of this drug screening microdevice beyond ovarian cancer.

## Key facts

- **NIH application ID:** 9623339
- **Project number:** 5R21CA216796-02
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Oliver Jonas
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $215,172
- **Award type:** 5
- **Project period:** 2018-01-08 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9623339

## Citation

> US National Institutes of Health, RePORTER application 9623339, Clinical Evaluation of an Implantable Lab-in-a-patient microdevice that measures in-situ response to therapies in advanced ovarian cancer (5R21CA216796-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9623339. Licensed CC0.

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