ITI-3000 for Carcinoma, Neuroendocrine

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Washington/Seattle Cancer Care Alliance, Seattle, WA
Carcinoma, Neuroendocrine+2 More
ITI-3000 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus-positive Merkel cell carcinoma (MCC).

Eligible Conditions

  • Carcinoma, Neuroendocrine

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Neuroendocrine

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Through study completion, up to 12 months.

Month 12
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
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.
Number of participants with changes from baseline in hematology lab results.
Number of participants with changes from baseline in physical exam findings.
Number of participants with changes from baseline in urinalysis lab results.
Number of participants with changes from baseline vital signs.

Trial Safety

Safety Progress

1 of 3

Other trials for Carcinoma, Neuroendocrine

Trial Design

1 Treatment Group

Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
1 of 1
Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: ITI-3000 · No Placebo Group · Phase 1

Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
Drug
Experimental Group · 1 Intervention: ITI-3000 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to 12 months.
Closest Location: University of Washington/Seattle Cancer Care Alliance · Seattle, WA
Photo of Seattle 1Photo of Seattle 2Photo of Seattle 3
2007First Recorded Clinical Trial
0 TrialsResearching Carcinoma, Neuroendocrine
16 CompletedClinical Trials

Who is running the clinical trial?

Immunomic Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
464 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a PS of 70 or less or an ECOG PS of 0-1.
You have a predicted life expectancy ≥ 3 months.
You have provided informed consent prior to initiation of any study procedures.
You have adequate renal function or a GFR of ≥ 50 mL/min/1.73 m2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.