Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05422781
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-06-01
Brief Title:
Study To Evaluate The Safety Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma MCC
Sponsor:
Immunomic Therapeutics Inc
Organization:
Immunomic Therapeutics Inc
Study Overview
Official Title:
A Phase I Open Label First In Humans FIH Study To Evaluate The Safety Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma MCC
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a single dose design examining 4 mg dose of the DNA vaccine ITI-3000 in participants who were diagnosed with polyomavirus-positive MCC histologically confirmed by an expert pathologist on standard clinical staining that may have been supplemented by specific staining for Cytokeratin 20 CK20 andor other markers used to distinguish MCC
Evidence of Merkel cell polyomavirus MCPyV in the tumor at initial presentation pre-therapy can be provided by a positive anti-MCPyV oncoprotein antibody AMERK Test
Participants in the study are those who are both diagnosed and have completed standard of care SOC surgical andor radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease NEAD Participants those who were previously diagnosed with MCC and had recurrence and also exhibited no evidence of active disease NEAD for more than 2 years prior to enrollment in the study
NEAD is confirmed by physical examination a negative AMERK test 74 STU in participants with a prior positive AMERK test or significantly decreased stable AMERK titers in 2 or more consecutive draws compared to prior positive AMERK test at the time of diagnosis in the setting of a negative computed tomography CT scan of the chest abdomen and pelvis or PET-CT within 3 months of enrollment into the study
Eight participants will be enrolled at 4 mg total DNA dose to assess safety tolerability and immunologic response to the ITI-3000 vaccine
Evidence of Merkel cell polyomavirus MCPyV in the tumor at initial presentation pre-therapy can be provided by a positive anti-MCPyV oncoprotein antibody AMERK Test
Participants in the study are those who are both diagnosed and have completed standard of care SOC surgical andor radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease NEAD Participants those who were previously diagnosed with MCC and had recurrence and also exhibited no evidence of active disease NEAD for more than 2 years prior to enrollment in the study
NEAD is confirmed by physical examination a negative AMERK test 74 STU in participants with a prior positive AMERK test or significantly decreased stable AMERK titers in 2 or more consecutive draws compared to prior positive AMERK test at the time of diagnosis in the setting of a negative computed tomography CT scan of the chest abdomen and pelvis or PET-CT within 3 months of enrollment into the study
Eight participants will be enrolled at 4 mg total DNA dose to assess safety tolerability and immunologic response to the ITI-3000 vaccine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None