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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04195347 | Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase | PHASE1 | RECRUITING | 42 | — | — | Sep 4, 2020 | Jan 1, 2029 | Jun 3, 2026 | 3 | United States |
Drug safety measuring the number of CTCAE grade 3-5 events
We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging
| Arm | Type | Description |
|---|---|---|
| CM4620 Treatment | EXPERIMENTAL | Phase I: Cohort 1 patients receive CM4620 IV at dose level 1 on days 1-4. Cohort 2 patients receive CM4620 IV at dose level 2 on days 1-4. Cohort 3 patients receive CM4620 IV at either dose level 1 or 2 on days 1-4 Phase II: Patients will receive CM4620 IV on days 1-4 at the recommended Phase II dose (RP2D) as determined in Phase I. |
| Name | Type | Description |
|---|---|---|
| CM4620 | DRUG | IV |
Inclusion Criteria: * Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute pancreatitis OR imaging findings consistent with acute pancreatitis. * Receipt of any form of asparaginase within the prior 49 days. * ...