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

NCT05422781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-11-22

No results posted yet for this 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).

Conditions

Interventions

DRUG

ITI-3000

ITI-3000 is a DNA vaccine (L-H LT S220A) which contains sequences for both LAMP1 and LTS220A, the truncated form of the LT antigen of MCPyV with a detoxifying serine to alanine mutation at position 220

Sponsors & Collaborators

  • Immunomic Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2023-06-27
Completion
2023-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422781 on ClinicalTrials.gov