ITI-3000 for Carcinoma, Neuroendocrine
Phase-Based Progress Estimates
Effectiveness
Safety
University of Washington/Seattle Cancer Care Alliance, Seattle, WA
Carcinoma, Neuroendocrine+2 More
ITI-3000 - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
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
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
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: DrugTrial 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
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 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.
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Conditions
Cancer Related
Treatments