A Phase 1/2 interventional study of IOV-5001 in Advanced Solid Tumors, Non-Small Cell Lung Cancer and Triple Negative Breast Cancer (TNBC), sponsored by Iovance Biotherapeutics, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Iovance Biotherapeutics, Inc. · Phase 1/2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 106 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Iovance Biotherapeutics, Inc. is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis:
NSCLC: Participant has a histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell, or mixed histologies) without epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) genomic alterations.
TNBC: Participant has a histologically or pathologically confirmed diagnosis of unresectable or Stage IV breast cancer.
CRC: Participant has a histologically or pathologically confirmed diagnosis of Stage IV CRC.
HNSCC: Participant has a histologically or pathologically confirmed diagnosis of Stage III or IV HNSCC not amenable to curative intent treatment.
Disease-specific criterion:
NSCLC: Radiographic disease progression occurred:
TNBC: Participant has received up to 3 prior lines of therapy. These must include at least one prior line of cytotoxic chemotherapy for unresectable or Stage IV breast cancer, regardless of ER, PR, or HER2 status at the time it was given.
CRC: Participant has received up to 3 prior lines of therapy. These must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (for RAS/rapidly accelerated fibrosarcoma [RAF] wild-type disease if the tumor originated in the left side of the colon), and an immune checkpoint inhibitor (for microsatellite instability high [MSI-H] or deficient mismatch repair [dMMR] disease.
HNSCC: Participant has received up to 3 prior lines of therapy. These must include an immune inhibitor and platinum-based chemotherapy unless platinum ineligible due to pre-existing hearing loss, Grade >= 2 tinnitus, Grade >= 2 peripheral neuropathy, or allergy to platinum.
Disease-specific criterion:
NSCLC: Participant has received up to 3 lines of prior therapy. These must include an appropriate health authority-approved targeted therapy for participants who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations) if eligible and available.
TNBC: Participant has progressed on or is ineligible for other standard of care therapies including, but not limited to: sacituzumab govitecan, poly(ADP-ribose) polymerase (PARP) inhibitors (if breast cancer gene [BRCA]1 or BRCA2 mutated), trastuzumab deruxtecan (if HER2low), and pembrolizumab (for PD-L1 combined positive score [CPS] >= 10).
CRC: Microsatellite instability and/or mismatch repair mutational status must have been previously determined based on archival tumor biopsies.
HNSCC: Participant has documented PD-L1 status.
Exclusion Criteria:
Biological: IOV-5001
Biological: IOV-5001
Biological: IOV-5001
Biological: IOV-5001
Biological: IOV-5001
IOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting.
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)
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
Iovance Biotherapeutics, Inc.