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

NCT07743723 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IOV-GE1-201
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief 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

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; 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)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 5 years

Secondary Outcomes (7)

• Complete Response (CR) Rate

  Up to 5 years

• Duration of Response (DOR)

  Up to 5 years

• Disease Control Rate (DCR)

  Up to 5 years

• Progression-Free Survival (PFS)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (5)

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

Interventions

IOV-5001 BIOLOGICAL

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

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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Colorectal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Central Study Contacts

Iovance Biotherapeutics Study Team

CONTACT

844-845-4682; Clinical.Inquiries@iovance.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2044
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share