Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IOV-4001 · 1 trial · 4 indications
The safety of IOV-4001 will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the investigator
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants with unresectable or metastatic melanoma |
| Cohort 2 | EXPERIMENTAL | Participants with Stage III or IV non-small-cell lung cancer |
| Name | Type | Description |
|---|---|---|
| IOV-4001 | BIOLOGICAL | A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2. |
Inclusion Criteria: 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC. 2. Participants who have received the following previous therapy: 1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks...
IOV-4001 is an investigational therapy being studied for the treatment of unresectable melanoma, as well as metastatic melanoma and stage III or IV non-small cell lung cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
IOV-4001 targets PD-1, a checkpoint protein involved in regulating immune responses. By targeting PD-1, the therapy aims to modulate the immune system's ability to fight cancer cells. This mechanism is being evaluated in the context of unresectable melanoma and other solid tumors.
IOV-4001 is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IOVA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
IOV-4001 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the therapy's safety and efficacy in specific cancer indications.
IOV-4001 is being studied in a Phase 1 clinical trial registered as NCT05361174. This trial is recruiting 53 participants in the United States and is investigating the therapy in adults with unresectable or metastatic melanoma or stage III or IV non-small cell lung cancer.