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IOV-5001 · 1 trial · 7 indications
The safety of IOV-5001 will be assessed based on the totality of DLT and AE data collected during this phase.
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.
| Arm | Type | Description |
|---|---|---|
| Phase 1: Safety Lead In | EXPERIMENTAL | - |
| Phase 2: Non-Small Cell Lung Cancer (NSCLC) | EXPERIMENTAL | - |
| Phase 2: Triple Negative Breast Cancer (TNBC) | EXPERIMENTAL | - |
| Phase 2: Colorectal Cancer (CRC) | EXPERIMENTAL | - |
| Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IOV-5001 | BIOLOGICAL | IOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting. |
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 histolo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
IOV-5001 is an investigational monoclonal antibody being developed by Iovance Biotherapeutics for the treatment of advanced solid tumors. It is a Phase 1 asset and has not been approved by any regulatory agency. It is being studied in adults with metastatic or unresectable solid tumors, including several specific cancer types.
IOV-5001 is being studied for advanced solid tumors, including non-small cell lung cancer, triple negative breast cancer, colorectal cancer, head and neck squamous cell carcinoma, and other metastatic or unresectable solid tumors. It is investigational and has not been approved for any indication.
IOV-5001 targets IL-12, a cytokine. As a monoclonal antibody directed at this cytokine target, IOV-5001 is designed to act on IL-12 biology in the tumor setting. The program is biomarker selected, meaning enrollment is guided by a biomarker rather than an unselected patient population.
IOV-5001 is being developed by Iovance Biotherapeutics, Inc., which trades on the Nasdaq under the ticker IOVA. Iovance is the sponsor of the clinical program evaluating the asset in advanced solid tumors.
IOV-5001 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. The program currently has one trial, which is active but not yet recruiting participants.
IOV-5001 is being evaluated in the Phase 1 study NCT07743723, titled A Study of IOV-5001 in Adults With Advanced Solid Tumors. The trial is controlled, is not randomized or double blinded, plans to enroll 106 adults aged 18 and older of all sexes, and is being conducted in the United States.