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Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

Phase 1

Waitlist Available

Led By Ashutosh K. Tewari, MD

Research Sponsored by Ashutosh Kumar Tewari

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 12

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a new treatment that injects a substance into specific areas of the body to help the immune system fight high-risk cancer. It aims to find the safest dose and understand any side effects. The treatment works by boosting the immune system to attack cancer cells, training it to recognize these cells better, and keeping it active against future cancer spread.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-Limiting Toxicity level

Secondary study objectives

Number of adverse events

Time to PSA progression

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment3 Interventions

Intratumoral (IT) Poly ICLC 1.0 mg IT once/week (week 1+2) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Group II: Cohort 3Experimental Treatment3 Interventions

Intratumoral (IT) Poly ICLC 1.0 mg IT once/week (week 1) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Group III: Cohort 2Experimental Treatment3 Interventions

Intratumoral (IT) Poly ICLC 0.5 mg IT once/week (week 1+2) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Group IV: Cohort 1Experimental Treatment3 Interventions

Intratumoral (IT) Poly ICLC 0.5 mg IT once/week (week 1) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intratumoral (IT) Poly ICLC 0.5 mg

2017

Completed Phase 1

~20

Carboxymethylcellulose

FDA approved

Carboxymethylcellulose

FDA approved