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Not yet recruitingNCT07743723Updated Sep 15, 2026

A Study of IOV-5001 in Adults With Advanced Solid Tumors

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
106
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Advanced Solid Tumors
  • Non-Small Cell Lung Cancer
  • Triple Negative Breast Cancer (TNBC)
  • Colorectal Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Metastatic Solid Tumors
  • Unresectable Solid Tumor

Keywords

  • TIL
  • Tumor Infiltrating Lymphocytes
  • Advanced Solid Tumors
  • Triple Negative Breast Cancer (TNBC)
  • Metastatic Solid Tumors
  • Unresectable Solid Tumors
  • Non-Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
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In context

Carcinoma, Non-Small-Cell Lung

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participant must be ≥ 18 years of age at the time of signing the informed consent.
  2. 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.

  3. Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.
  4. Disease-specific criterion:

    NSCLC: Radiographic disease progression occurred:

    • After having received platinum-based chemotherapy and an immune checkpoint inhibitor, either administered concurrently or sequentially for Stage IV disease.
    • Within 6 months of completion of the platinum component of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and having progressed after receiving an immune checkpoint inhibitor in the neoadjuvant, adjuvant, or metastatic setting.

    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.

  5. 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.

  6. The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of > 6 months.
  7. Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for IOV-5001 generation.

Exclusion criteria

Exclusion Criteria:

  1. Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.
  2. Participant has an active medical illness(es) that, in the opinion of the investigator would pose increased risks for study participation. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening.
  3. Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
  4. Participant has a history of hypersensitivity to any component of the study intervention.
  5. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated > 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence including, but not limited to: in situ carcinoma of the cervix, early stage skin cancer, including non-melanoma skin cancer, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast, prostate cancer with Gleason score ≤ 6, or superficial bladder cancer).
  6. Participant has a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
  7. Participant requires systemic steroid therapy > 10 mg/day of prednisone or another steroid equivalent dose. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or another steroid equivalent dose may be eligible.
  8. Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD preparative regimen.
  9. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    Phase 1: Safety Lead In

    Biological: IOV-5001

  • Experimental
    Phase 2: Non-Small Cell Lung Cancer (NSCLC)

    Biological: IOV-5001

  • Experimental
    Phase 2: Triple Negative Breast Cancer (TNBC)

    Biological: IOV-5001

  • Experimental
    Phase 2: Colorectal Cancer (CRC)

    Biological: IOV-5001

  • Experimental
    Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC)

    Biological: IOV-5001

Interventions

  • BiologicalIOV-5001

    IOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting.

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What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

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Study locations

1 site
  • Weill Cornell Medicine-New York Presbyterian Hospital
    New York, New York 10065, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07743723
Lead sponsor
Iovance Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2034 (estimated)
Completion
Mar 2044 (estimated)
Last update
Sep 15, 2026

Study contacts

Iovance Biotherapeutics Study Team
Contact
Clinical.Inquiries@iovance.com
844-845-4682

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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