drugset / Trial / NCT04751786
Dose Escalation Study of Immunomodulatory Nanoparticles
NaSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-01-11
- Primary completion
- 2025-07
- Completion
- 2025-12
Publications
- Results Dolen Y, Kreutz M, Gileadi U, Tel J, Vasaturo A, van Dinther EA, van Hout-Kuijer MA, Cerundolo V, Figdor CG. Co-delivery of PLGA encapsulated invariant NKT cell agonist with antigenic protein induce strong T cell-mediated antitumor immune responses. Oncoimmunology. 2015 Aug 12;5(1):e1068493. doi: 10.1080/2162402X.2015.1068493. eCollection 2016.
- Creemers JHA, Pawlitzky I, Grosios K, Gileadi U, Middleton MR, Gerritsen WR, Mehra N, Rivoltini L, Walters I, Figdor CG, Ottevanger PB, de Vries IJM. Assessing the safety, tolerability and efficacy of PLGA-based immunomodulatory nanoparticles in patients with advanced NY-ESO-1-positive cancers: a first-in-human phase I open-label dose-escalation study protocol. BMJ Open. 2021 Nov 30;11(11):e050725. doi: 10.1136/bmjopen-2021-050725.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRECIOUS-01 | Other / unclassified | 0.4 mg/kg | Intravenous |
| Subject | PRECIOUS-01 | Other / unclassified | 0.8 mg/kg | Intravenous |
| Subject | PRECIOUS-01 | Other / unclassified | 1.6 mg/kg | Intravenous |
Indications
No indication recorded.