← Back to Search

Virus Therapy

ITI-3000 for Neuroendocrine Carcinoma

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

Study Summary

This trial will test ITI-3000, a possible treatment for polyomavirus-positive Merkel cell carcinoma (MCC). It will measure how safe and tolerated the drug is, as well as its ability to provoke an immune response.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any associated health risks of taking ITI-3000?

"The safety of ITI-3000 has been given a score of 1 due to the minimal data backing its efficacy and risk mitigation. This is in accordance with it being a Phase 1 trial."

Answered by AI

Does this clinical experiment have any open recruitment opportunities?

"Affirmative. Clinicaltrials.gov presents evidence that this medical trial is actively recruiting participants, with an initial post date of June 13th 2022 and a recent update on August 1st 2022. To complete the study 8 volunteers are needed from one location."

Answered by AI

What is the present number of participants enrolled in this trial?

"Affirmative. Details hosted on clinicaltrials.gov verify that this medical trial is actively seeking participants, which was initially published on June 13th 2022. 8 patients are needed from one premises for the study to proceed as planned."

Answered by AI

Who else is applying?

What site did they apply to?
University of Washington/Seattle Cancer Care Alliance
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have had Merkel Cell for 4 years.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
2022. "Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422781.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top