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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04574401 | A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy | PHASE1 | COMPLETED | 24 | — | — | Oct 10, 2020 | Sep 20, 2021 | Oct 22, 2021 | 1 | United States |
Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels |
| Name | Type | Description |
|---|---|---|
| IS-002 | DRUG | Intravenous injection of IS-002 Investigational Drug |
Inclusion Criteria: * Subject is between the ages of 18 and 75. * Subject has a confirmed adenocarcinoma by histology of the prostate. * Subject has CAPRA \> 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases * Subject is scheduled to u...