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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02559674 | QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-Paclitaxel | PHASE1 | COMPLETED | 8 | — | — | Jul 1, 2016 | Feb 21, 2018 | Jan 27, 2020 | 1 | United States |
Determine the maximum tolerated dose (MTD) level and designate the recommended dose level for phase II.
Number and severity of treatment related adverse events (AEs) that occur or worsen after the first dose of study treatment
Determine the 8.5 month overall survival of treated patients
| Arm | Type | Description |
|---|---|---|
| Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxel | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | BIOLOGICAL | Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of gemcitabine given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles. |
| Nab-paclitaxel | BIOLOGICAL | Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of nab-paclitaxel given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles. |
| ALT-803 | BIOLOGICAL | Subcutaneous Injection; Patients will receive two 4-week cycles consisting of ALT-803 given on Day 2, 9, 16, 30, 37, and 44. Eligible patients may receive up to 10 additional treatment cycles. |
DISEASE CHARACTERISTICS: Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of pancreatic cancer. * For dose escalation phase (Phase Ib) distant metastatic disease or unresectable disease and not a candidate for down staging to resection. * For expansion phase (Phase II...