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Virus Therapy

Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)

Phase 1
Waitlist Available
Research Sponsored by Immunomic Therapeutics, Inc.
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 through study completion, up to 12 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new vaccine called ITI-3000 in patients with a specific type of skin cancer who have finished standard treatments and currently show no signs of active disease. The vaccine aims to help their immune systems recognize and attack any remaining cancer cells.

Eligible Conditions
  • Cutaneous Neuroendocrine Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Number of participants with Dose Limiting Toxicities (DLTs).
Number of participants with changes from baseline in chemistry lab results.
+4 more
Other study objectives
Exploratory endpoints include immune assessments anti- MCPyV LT antibodies
Exploratory endpoints include immune assessments for anti-MCPyV T-cell response
Exploratory endpoints include immune assessments for anti-MCPyV oncoprotein antibodies

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)Experimental Treatment1 Intervention
Eight participants with MCC (\> 1.0 years since definitive treatment or participants who had recurrence \>2 years since evidence of disease) and NEAD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ITI-3000
2022
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Immunomic Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
470 Total Patients Enrolled
~2 spots leftby Dec 2025
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