Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IO-108 · 1 trial · 1 indication
safety and tolerability as measured by the incidence of treatment-emergent adverse events and serious adverse events
MTD will be determined through observation of pre-determined DLTs in each dose cohort
safety and tolerability as measured by the incidence of treatment-emergent adverse events and discontinuation due to TEAEs
| Arm | Type | Description |
|---|---|---|
| IO-108 Monotherapy | EXPERIMENTAL | Treatment of patients with advanced solid tumors with IO-108 monotherapy |
| IO-108 + pembrolizumab combination therapy | EXPERIMENTAL | Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of pembrolizumab |
| IO-108 + cemiplimab combination therapy | EXPERIMENTAL | Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of cemiplimab |
| Name | Type | Description |
|---|---|---|
| IO-108 | BIOLOGICAL | IO-108 given as monotherapy |
| IO-108 + pembrolizumab combination therapy | BIOLOGICAL | IO-108 and fixed dose pembrolizumab combination therapy |
| IO-108 + cemiplimab combination therapy | BIOLOGICAL | IO-108 and fixed dose cemiplimab combination therapy |
Inclusion Criteria: 1. Patients must be ≥18. 2. Has any histologically- or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, has been intolerant to, or has been ineligible for standard systemic therapy known to confer clinical benefit. Solid tumors of any...
IO-108 is an investigational monoclonal antibody being studied for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, having completed a first-in-human trial as a single agent and in combination with a PD-1 immune checkpoint inhibitor in patients with advanced solid tumors.
IO-108 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol REGN. The company is conducting clinical research to evaluate the safety and efficacy of IO-108 in patients with advanced solid tumors.
IO-108 is in Phase 1 clinical development. A Phase 1 trial, NCT05054348, has been completed, evaluating IO-108 as a single agent and in combination with a PD-1 immune checkpoint inhibitor in patients with advanced solid tumors. The drug is investigational and not yet approved.
IO-108 has one completed clinical trial, NCT05054348, a first-in-human study of IO-108 as a single agent and in combination with a PD-1 immune checkpoint inhibitor in patients with advanced solid tumors. The trial enrolled 91 participants in the United States and was not randomized or double-blinded.
IO-108 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial has evaluated its use in advanced solid tumors, but it has not yet received regulatory approval for any indication.