Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02270372 | Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer | PHASE1 | COMPLETED | 22 | — | — | Nov 1, 2014 | Jun 1, 2016 | May 17, 2018 | 4 | United States |
Assessment of the adverse event profile as an indication of overall safety and tolerability of the combination treatment with ONT-10 and varlilumab
| Arm | Type | Description |
|---|---|---|
| Drug Combination | EXPERIMENTAL | The drug combination of ONT-10 and varilumab |
| Name | Type | Description |
|---|---|---|
| ONT-10, Varlilumab combination | BIOLOGICAL | ONT-10 a liposomal synthetic glycopolypeptide MUC1 targeted antigen formulated with PET Lipid A adjuvant. Varlilumab is a recombinant, fully human mAb of the IgG1κ isotype that specifically binds human CD27. |
Inclusion Criteria: 1. Be at least 18 years of age at the time of consent 2. Life expectancy of at least 6 months, in the opinion of the investigator 3. Have histologically confirmed breast or ovarian carcinoma 4. Have evidence of persistent, recurrent, or progressive disease for which there is no ...