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Updated: Oct 11, 2025
Evaluation of the In vivo Antitumor Activity of Polyanhydride IL-1α Nanoparticles
Published on: June 28, 2021
Assessing the safety, tolerability and efficacy of PLGA-based immunomodulatory nanoparticles in patients with
Jeroen H A Creemers1,2, Inka Pawlitzky3, Konstantina Grosios4
1Department of Tumor Immunology, Radboudumc, Nijmegen, The Netherlands.
Introduction:
The undiminished need for more effective cancer treatments stimulates the development of novel cancer immunotherapy candidates. The archetypical cancer immunotherapy would induce robust, targeted and long-lasting immune responses while simultaneously circumventing immunosuppression in the tumour microenvironment. For this purpose, we developed a novel immunomodulatory nanomedicine: PRECIOUS-01. As a PLGA-based nanocarrier, PRECIOUS-01 encapsulates a tumour antigen (NY-ESO-1) and an invariant natural killer T cell activator to target and augment specific antitumour immune responses in patients with NY-ESO-1-expressing advanced cancers.
Methods And Analysis:
This open-label, first-in-human, phase I dose-escalation trial investigates the safety, tolerability and immune-modulatory activity of increasing doses of PRECIOUS-01 administered intravenously in subjects with advanced NY-ESO-1-expressing solid tumours. A total of 15 subjects will receive three intravenous infusions of PRECIOUS-01 at a 3-weekly interval in three dose-finding cohorts. The trial follows a 3+3 design for the dose-escalation steps to establish a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). Depending on the toxicity, the two highest dosing cohorts will be extended to delineate the immune-related parameters as a readout for pharmacodynamics. Subjects will be monitored for safety and the occurrence of dose-limiting toxicities. If the MTD is not reached in the planned dose-escalation cohorts, the RP2D will be based on the observed safety and immune-modulatory activity as a pharmacodynamic parameter supporting the RP2D. The preliminary efficacy will be evaluated as an exploratory endpoint using the best overall response rate, according to Response Evaluation Criteria in Solid Tumors V.1.1.
Ethics And Dissemination:
The Dutch competent authority (CCMO) reviewed the trial application and the medical research ethics committee (CMO Arnhem-Nijmegen) approved the trial under registration number NL72876.000.20. The results will be disseminated via (inter)national conferences and submitted for publication to a peer-reviewed journal.
Trial Registration Number:
NCT04751786.
Insights
This Phase I trial evaluates PRECIOUS-01, a novel nanomedicine for advanced cancers expressing NY-ESO-1. It assesses safety, tolerability, and immune response to establish a recommended dose for future studies.
Area of Science:
- Immunology
- Oncology
- Nanomedicine
Background:
- The need for effective cancer treatments drives the development of novel immunotherapies.
- PRECIOUS-01 is a new nanomedicine designed to enhance anti-tumor immune responses.
- It targets NY-ESO-1 expressing advanced cancers.
Purpose of the Study:
- To evaluate the safety and tolerability of PRECIOUS-01 in a Phase I dose-escalation trial.
- To assess the immune-modulatory activity of PRECIOUS-01.
- To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
Main Methods:
- Open-label, first-in-human, Phase I dose-escalation study.
- 15 subjects with advanced NY-ESO-1-expressing solid tumors receive intravenous PRECIOUS-01 in three dose cohorts.
- 3+3 design to establish MTD/RP2D, with pharmacodynamic assessments and preliminary efficacy evaluation.
Main Results:
- The study is ongoing and results are pending.
- Safety, tolerability, and immune-modulatory activity will be assessed.
- Preliminary efficacy will be evaluated based on overall response rate.
Conclusions:
- PRECIOUS-01 is a promising novel immunomodulatory nanomedicine for advanced cancers.
- The Phase I trial will establish the safety profile and optimal dosing for future studies.
- This research aims to improve targeted anti-tumor immune responses.
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