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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05607953 | Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma | PHASE1 | ACTIVE NOT_RECRUITING | 60 | — | — | Mar 1, 2023 | Oct 1, 2027 | Jul 4, 2025 | 1 | United States |
As a measure of safety, adverse events will be graded according to CTCAE v5.0
A standard 3+3 dose-escalation design will be employed to determine the MTD or optimal biologic dose.
| Arm | Type | Description |
|---|---|---|
| SD-101 | EXPERIMENTAL | Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration. |
| Name | Type | Description |
|---|---|---|
| SD-101 | DRUG | SD-101 doses are administered via PRVI using the PEDD method of administration |
| anti-PD-1 | BIOLOGICAL | In the Phase 1b, anti-PD-1 will be administered together with SD-101 |
Inclusion Criteria: * Patients ≥18 years of age with histologically or cytologically confirmed evaluable or measurable locally advanced unresectable PDAC, or previously confirmed disease in the absence of a documented complete pathologic response. * Performance status score of 0 or 1 on the ECOG PS...