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Dose Escalation Study of Immunomodulatory Nanoparticles

NCT04751786 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-31

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

PRECIOUS-01

Subjects will be enrolled in one of three dosing cohorts (three subjects per cohort for the planned dose escalation with a planned extension to a total of six subjects for the two highest dosing cohorts for the evaluation of the pharmacodynamic effects of PRECIOUS-01 for determination of the RP2D, if MTD is not reached).

Sponsors & Collaborators

  • CATO-SMS

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Petronella B. Ottevanger, MD, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751786 on ClinicalTrials.gov