Status:
ACTIVE_NOT_RECRUITING
A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial
Lead Sponsor:
ImmuneSensor Therapeutics Inc.
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a rollover study from parent protocol IMSA101-101 for adult patients with advanced malignancies that were previously receiving IMSA101 and who would continue to receive benefit with study trea...
Detailed Description
The following methodology applies to all patients: * Treatment cycles will be 28 days in duration with lesions injected every 2 weeks. IMSA101 dose level will remain the same as at the time of the ro...
Eligibility Criteria
Inclusion
- Signed informed consent and mental capability to understand the informed consent
- Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment
- Deriving clinical benefit from study treatment, as determined by the investigator
- Must have fulfilled all required assessments in parent protocol IMSA101-101
- Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
Exclusion
- Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study
- Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06026254
Start Date
September 15 2023
End Date
September 1 2025
Last Update
November 18 2024
Active Locations (2)
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1
Honor Health
Scottsdale, Arizona, United States, 85260
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093