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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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
IOV-5001 is an investigational monoclonal antibody being developed for the treatment of advanced solid tumors, including non-small cell lung cancer, triple negative breast cancer, colorectal cancer, head and neck squamous cell carcinoma, and metastatic or unresectable solid tumors. It is currently in Phase 1 clinical development.
IOV-5001 targets IL-12, a cytokine involved in immune signaling. By targeting IL-12, the antibody is designed to modulate immune responses in the tumor microenvironment. This mechanism is being studied in the context of advanced solid tumors.
IOV-5001 is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IOVA. The company is conducting a Phase 1 clinical trial to evaluate the drug in adults with advanced solid tumors.
IOV-5001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety and tolerability of IOV-5001 in patients with advanced solid tumors.
IOV-5001 is being studied in a single Phase 1 clinical trial with the identifier NCT07743723, titled 'A Study of IOV-5001 in Adults With Advanced Solid Tumors.' The trial is not yet recruiting and plans to enroll approximately 106 participants aged 18 years and older.
No alternative names for IOV-5001 have been disclosed. It is a distinct investigational monoclonal antibody targeting IL-12, developed by Iovance Biotherapeutics. The drug is currently being evaluated in a Phase 1 trial for advanced solid tumors.