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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01040000 | QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer | PHASE1 | COMPLETED | 94 | — | — | Jan 1, 2012 | Mar 1, 2017 | Aug 4, 2017 | 6 | United States |
Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C (NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor.
| Arm | Type | Description |
|---|---|---|
| NPC-1C/NEO-102 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NPC-1C/NEO-102 | DRUG | Subjects will receive NPC-1C at a dose of 3.0 mg/kg. NPC-1C will be given intravenously (by vein) over approximately 1-6 hours, once every 2 weeks for 4 doses per course. Courses will be repeated in the absence of disease progression or unacceptable toxicity. |
INCLUSION CRITERIA: * Age: \>/= 18 * Diagnosis: * Histologically confirmed recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas who have progressed after front line chemotherapy, OR * Histologically confirmed metastatic colorectal adenocarcinoma who have progre...