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Clinical trial intelligence report
First-in-human Phase I Dose Escalation Study Assessing Safety, Tolerability and Preliminary Efficacy of Immunomodulatory Nanoparticles
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT04751786-Jul 28, 2026
NCT ID
NCT04751786
Status
ACTIVE_NOT_RECRUITING
Phase
Phase 1
Sponsor
Radboud University Medical Center
Executive brief
Investment-Ready Snapshot
The PRECIOUS-01 trial, sponsored by Radboud University Medical Center, is exploring a novel immunotherapeutic approach using PLGA nanoparticles to deliver iNKT cell agonists and tumor antigens for patients with NY-ESO-1-positive cancers. Given the prevalence of NY-ESO-1 expression in various malignancies (25-30% in advanced cancers), this asset targets a significant patient population with unmet medical needs. The trial's focus on safety, tolerability, and preliminary efficacy positions it strategically within the competitive landscape of immuno-oncology, where novel delivery systems and combination therapies are increasingly sought after. Successful outcomes could lead to further development and potential partnerships or licensing opportunities, particularly in the context of expanding immunotherapy portfolios.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT04751786
Indication
Advanced Solid Tumor
Modality
small molecule
Target
Invariant natural killer T cell (iNKT) activation via threitolceramide-6 (ThrCer6, IMM60) and targeting of NY-ESO-1 cancer-testis antigen peptides.
Intervention
PRECIOUS-01
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.