Not yet recruitingPhase 1 / Phase 2

A Study of IOV-5001 in Adults With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests IOV-5001, a treatment made from a person's own immune cells found inside their tumor. It is for adults with certain advanced cancers that have grown or spread after 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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old, and scans must show that your cancer got worse after your latest treatment.
  • Lung cancer: You must have stage IV non-small cell lung cancer without EGFR, ALK, or ROS1 gene changes. You must meet rules for past chemotherapy, immune treatment, and targeted drugs, with no more than 3 past lines of treatment.
  • Breast cancer: Your cancer must be stage IV or unable to be removed by surgery. You must have had 1 to 3 past lines of treatment, including chemotherapy. Other required standard treatments must have stopped working or not be right for you.
  • Colon or rectal cancer: You must have stage IV cancer and no more than 3 past lines of treatment. You must have received the required chemotherapy and other drugs, and had tests for certain tumor gene features.
  • Head and neck cancer: You must have stage III or IV squamous cell cancer that cannot be treated with the goal of a cure. You must have had no more than 3 past lines of treatment, including immune treatment and platinum chemotherapy unless certain health problems prevent its use. Your tumor's PD-L1 test result must be known.
  • You must be fully active or able to do light work despite limits on harder activity.
  • You must be expected to live longer than 6 months.
  • You must have one or more tumors that can be removed to make IOV-5001. The tissue must meet the study's size rule of at least 1.5 cm across its shorter side.

Who can't join

  • You have untreated cancer that has spread to the brain and causes symptoms. Some people with cancer in the brain may qualify after study review.
  • You have an illness that makes joining unsafe, or an active infection found at screening or needing ongoing treatment throughout the body.
  • You have an immune system disorder, such as severe combined immunodeficiency (SCID) or AIDS.
  • You have had an allergic reaction to any part of the study treatment.
  • You had another cancer within the past 3 years. Some cancers that need no treatment or were cured more than a year ago may be allowed.
  • You have had an organ transplant from a donor, or cell therapy with chemotherapy to prepare for it within the past 20 years.
  • You need more than 10 mg of prednisone daily, or an equal dose of another steroid. Lower-dose steroids to replace missing adrenal hormones may be allowed.
  • You received or plan to receive a live or weakened-live vaccine within 28 days before the study's preparation treatment. You also cannot be in another treatment study, unless you are only in follow-up; studies that only observe you are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: 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.

Study sites (1)

NY