Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anti-Macrophage Migration Inhibitory Factor Antibody · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Malignant Solid Tumor (Arm 1) | EXPERIMENTAL | Dose Escalation Phase- Standard dose escalation of anti-MIF antibody in 5 dose groups of 3-6 participants each according to 3+3 design: 1. Dose escalation will be performed after safety data review, following completion of dosing of each cohort. -\> 2. Safety data review. If dose escalation permissible -\> 3. Next dose group -\> 4. Safety data review, etc. Dose Expansion Phase- Enrollment of up to 6 participants to receive anti-MIF antibody (at the maximum tolerated dose or lower) in order to gain further experience with the investigational product at a specific dose level(s). |
| Metastatic Adenocarcinoma of the Colon or Rectum (Arm 2) | EXPERIMENTAL | Dose Escalation Phase- Standard dose escalation of anti-MIF antibody in 3 dose groups of 3-6 participants each according to 3+3 design: 1. Dose escalation will be performed after safety data review, following completion of dosing of each cohort. -\> 2. Safety data review. If dose escalation permissible -\> 3. Next dose group -\> 4. Safety data review, etc. Dose Expansion Phase- Enrollment of up to 6 participants to receive anti-MIF antibody (at the maximum tolerated dose or lower) in order to gain further experience with the investigational product at a specific dose level(s). |
| Name | Type | Description |
|---|---|---|
| Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody | BIOLOGICAL | * Dosing every 2 weeks * Intravenous injection |
Main Inclusion Criteria: * Males and females 18 years of age and older at the time of screening * Anticipated life expectancy \> 3 months at the time of screening * Arm 1 only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is...