Dose Escalation Study of Immunomodulatory Nanoparticles begins in Netherlands
Radboud University is starting a new clinical trial of Dose Escalation Study of Immunomodulatory Nanoparticles.
PRECIOUS-01 is an immunomodulating agent composed of the invariant natural killer T cell (iNKT) activator threitolceramide-6 (ThrCer6, IMM60) and the New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) cancer-testis antigen peptides encapsulated in a poly(lactic-co-glycolic acid) (PLGA) nanoparticle.
PRECIOUS-01 is being developed for the treatment of patients with NY-ESO-1-positive cancers.
In the rapidly evolving treatment landscape of advanced solid tumors, immunotherapeutic approaches have revolutionized cancer care for patients. Despite these advances, there is an undiminished need for the development of novel immunotherapeutic treatment modalities that are able to orchestrate effective anti-tumor immune responses. The investigators study a new class of immunomodulatory nanomedicines: PLGA nanoparticles loaded with a tumor antigen and an iNKT cell agonist.
PLGA is a biodegradable polymer with minimal (systemic) toxicity, approved by the Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) to be used in various drug-carrying platforms.Tumor antigens and immunomodulatory molecules can be co-encapsulated in PLGA-based nanoparticles. In preclinical studies, these PLGA-based nanoparticles can induce anti-tumor immune responses. The investigators aim to explore PLGA-based nanoparticles containing the tumor antigen NY-ESO-1 and the iNKT cell activator IMM60 for their capacity to induce anti-tumor responses in cancer patients.
The clinical trial started in January 11, 2021 and will continue throughout December 2022.
There are a number of conditions that do not allow participation, such as:
- Second malignancy in the previous 2 years, with the exception of adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
- Clinical suspicion or radiological evidence of active brain metastases. Patients with brain metastases that have been treated previously and are proven stable (computed tomography [CT] or magnetic resonance imaging [MRI] < 30 days) and without steroids for > 3 months are allowed.
- Concomitant use of oral or i.v. immunosuppressive drugs. Inhaled, topical or intranasal steroids and adrenal replacement steroids < 10 mg/day (prednisone equivalent) are permitted in the absence of auto-immune disease.
- Uncontrolled infectious disease, i.e. negative testing for human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and syphilis (Treponema Pallidum Hemagglutination Assay [TPHA]).
- History of clinically significant cardiovascular disease (≤ 6 months prior to Day 1 on trial) such as stroke, Transient Ischemic Attack (TIA), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, relevant pathological ECG findings or uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg).
The full list can be viewed at the link below.
The contacts and locations are the Radboudumc, Nijmegen, Gelderland, Netherlands.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04751786
