A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors
This study is the first-in-human study of IOV-5001. IOV-5001 is expected to have antitumor activity through its capacity to directly target and kill the tumor cells in a manner that is similar to non-genome-edited TIL products, but with the potential for enhanced antitumor activity because IOV-5001 is genetically modified to express inducible membrane-tethered interleukin-12 (TeIL-12). IL-12 is a potent cytokine known to enhance T-cell responses. As such, IOV-5001 represents a strategy to augment the cytotoxic activity of TIL through inducible localized presentation of TeIL-12 without systemic exposure to IL-12 cytokines, thereby improving the safety profile.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
IOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting.
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States
Phase 1: Safety Assessment
The safety of IOV-5001 will be assessed based on the totality of DLT and AE data collected during this phase.
Time frame: Up to 30 days
Phase 2: Efficacy Measured by Overall Response Rate (ORR)
To evaluate the efficacy of IOV-5001 in select solid tumor indications as measured by ORR per RECIST v1.1 as assessed by the investigator.
Time frame: Up to 5 years
Complete Response (CR) Rate
CR rate is defined as the proportion of participants who have a confirmed CR per RECIST v1.1 from the date of the IOV-5001 infusion until disease progression, the start of a new anticancer therapy, or death due to any cause, whichever occurs first (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Time frame: Up to 5 years
Duration of Response (DOR)
DOR is measured from the time that criteria are met for CR or PR per RECIST v1.1 until disease progression or death due to any cause (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Time frame: Up to 5 years
Disease Control Rate (DCR)
DCR is measured by the percentage of participants with a best overall confirmed response of CR or PR at any time or SD ≥ 4 weeks per RECIST v1.1 from the date of the IOV-5001 infusion until disease progression, the start of a new anticancer therapy, or death due to any cause, whichever occurs first (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Time frame: Up to 5 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date of lifileucel infusion until disease progression per RECIST v1.1 as assessed by investigator or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
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Time frame: Up to 5 years
Overall Survival (OS)
OS is the time from the date of the IOV-5001 infusion to death due to any cause (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Time frame: Up to 5 years
Safety and Tolerability
The safety of IOV-5001 will be characterized by the severity, seriousness, relationship to study intervention, and characteristics of REAEs and TEAEs, including SAEs, study intervention-related AEs, and AEs leading to early discontinuation of study intervention or death up to 5 years after initiation of study intervention.
Time frame: Up to 5 years
Product Feasibility
Product feasibility will be assessed by the number and percentage of products successfully manufactured among the participants who had tumor resected
Time frame: Up to Day 0