NCT06343077

Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

Recruiting now Phase 2 Last updated 2 April 2024

What this trial tests

Phase 2 trial testing Poly-ICLC intramuscular (IM) injection in Prostate Cancer Patients on Active Surveillance in 114 participants. Currently enrolling.

Timeline

16 January 2024

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Ashutosh Kumar Tewari
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	114
Start date	16 January 2024
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Poly-ICLC intramuscular (IM) injection — full drug profile →
• Poly-ICLC, Intertumoral (IT) injection — full drug profile →

Conditions studied

• Prostate Cancer Patients on Active Surveillance — all drugs for Prostate Cancer Patients on Active Surveillance →

Sponsor

Ashutosh Kumar Tewari — full company profile →

Who can join

18 and older, male only, with Prostate Cancer Patients on Active Surveillance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanomaterials-driven in situ vaccination: a novel frontier in tumor immunotherapy.
   Liu N, Wang X, Wang Z, Kan Y, et al · · 2025 · cited 16× · PMID 40247328 · DOI 10.1186/s13045-025-01692-4
2. Nano Approaches to Nucleic Acid Delivery: Barriers, Solutions, and Current Landscape.
   Gonzalez JC, Park KW, Evans DB, Sharma R, et al · · 2025 · cited 7× · PMID 40223402 · DOI 10.1002/wnan.70010
3. Current status and future directions of nanovaccine for cancer: a bibliometric analysis during 2004-2023.
   Hou Y, Li Y, Zhang Y, Zhang J, et al · · 2024 · cited 7× · PMID 39136021 · DOI 10.3389/fimmu.2024.1423212
4. Therapeutic Immunomodulation of Tumor-Lymphatic Crosstalk via Intratumoral Immunotherapy.
   Lucas SN, Thomas SN. · · 2024 · cited 4× · PMID 39478434 · DOI 10.1021/acs.molpharmaceut.4c00692
5. Targeting pattern recognition receptors for cancer therapy: Mechanisms and strategies.
   Ouyang D, Chen R, Xie H, Yang X, et al · · 2025 · cited 1× · PMID 41311391 · DOI 10.1016/j.apsb.2025.09.007