Advanced Solid TumorsPhase 1/2NCT07743723
A Study of IOV-5001 in Adults With Advanced Solid Tumors
A Phase 1/2 study testing IOV-5001 in people with Advanced Solid Tumors and Non-Small Cell Lung Cancer, run by Iovance Biotherapeutics, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer (TNBC)
- What is being tested?
- IOV-5001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2044
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
- 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.
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- Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.
- 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.
- 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.
- The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of > 6 months.
- 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.
Who cannot join
- Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.
- 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.
- Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
- Participant has a history of hypersensitivity to any component of the study intervention.
- 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).
- Participant has a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
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- 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.
- Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD preparative regimen.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
About this study
Official title: 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
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.
- Conditions
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer (TNBC), Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Metastatic Solid Tumors
- Being tested
- IOV-5001
- 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)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOV-5001Biological
IOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Safety Lead In | Experimental | Not described Receives: Biological: IOV-5001 |
| Phase 2: Non-Small Cell Lung Cancer (NSCLC) | Experimental | Not described Receives: Biological: IOV-5001 |
| Phase 2: Triple Negative Breast Cancer (TNBC) | Experimental | Not described Receives: Biological: IOV-5001 |
| Phase 2: Colorectal Cancer (CRC) | Experimental | Not described Receives: Biological: IOV-5001 |
| Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC) | Experimental | Not described Receives: Biological: IOV-5001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Measured: Up to Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2034 (estimated)
- Study completionMar 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743723
- Sponsor's protocol ID
- IOV-GE1-201
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07743723
- Acronym / sponsor ID
- IOV-GE1-201
- Conditions
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer (TNBC), Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Metastatic Solid Tumors
- 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)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Mar 2044 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Safety Lead In | Experimental | Biological: IOV-5001 |
| Phase 2: Non-Small Cell Lung Cancer (NSCLC) | Experimental | Biological: IOV-5001 |
| Phase 2: Triple Negative Breast Cancer (TNBC) | Experimental | Biological: IOV-5001 |
| Phase 2: Colorectal Cancer (CRC) | Experimental | Biological: IOV-5001 |
| Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC) | Experimental | Biological: IOV-5001 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
- 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.
Key exclusion criteria (9 listed)
- Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.
- 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.
- Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
- Participant has a history of hypersensitivity to any component of the study intervention.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOV-5001IOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting. | Biological | Phase 1: Safety Lead In, Phase 2: Colorectal Cancer (CRC), Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC), Phase 2: Non-Small Cell Lung Cancer (NSCLC), Phase 2: Triple Negative Breast Cancer (TNBC) |
Primary outcome
Phase 1: Safety Assessment
Time frame: Up to 30 days
The safety of IOV-5001 will be assessed based on the totality of DLT and AE data collected during this phase.
Phase 2: Efficacy Measured by Overall Response Rate (ORR)
Time frame: Up to 5 years
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.
7 secondary outcomes
Complete Response (CR) Rate
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: Up to 5 years
Disease Control Rate (DCR)
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Safety and Tolerability
Time frame: Up to 5 years
Product Feasibility
Time frame: Up to Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IOV-5001 in people with Advanced Solid Tumors and Non-Small Cell Lung Cancer, run by Iovance Biotherapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iovance Biotherapeutics Study Team (844-845-4682, Clinical.Inquiries@iovance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Safety Assessment (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.