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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03937895 | Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab in Advanced Biliary Tract Cancer | PHASE1 | COMPLETED | 40 | — | — | Dec 3, 2019 | Jun 8, 2021 | Mar 29, 2022 | 2 | South Korea |
DLT (Dose Limiting Toxicity) Assessment
ORR (Objective Response Rate, sum of PR and CR) is finally evaluated In the third tumor response evaluation by CT(according to RECIST V1.1).
| Arm | Type | Description |
|---|---|---|
| Experimental: single arm | EXPERIMENTAL | * Biological: 'SMT-NK' Inj. (allogeneic Natural Killer cell) weekly administration for 2 weeks. After that, 1 week is a withdrawal period. (Phase 1: up to \*cycle 3, Phase 2a: up to cycle 9) * Drug: Pembrolizumab administration of Pembrolizumab 200mg/m2 at first week during cycle. * Cycle: 1 cycle is 3 weeks in total.'SMT-NK' Inj is administered at first and second week, and Pembrolizumab is administered at first week. The third week is a withdrawal period. |
| Name | Type | Description |
|---|---|---|
| 'SMT-NK' Inj (allogeneic Natural Killer cell) | BIOLOGICAL | In 120 mL, 3x10\^6 (± 20%) cells/kg. weekly administration via Intravenous for 2 weeks. After that, 1 week is a withdrawal period. |
| Pembrolizumab Injection [Keytruda] | DRUG | Administration via Intravenous of 200 mg every 3 weeks(one administration per cycle.). |
\[Inclusion Criteria\] Patients who received a histopathological or cytologic diagnosis of nonresectable, advanced biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer) and patients with refractory disease after chemotherapy and/or patients who have difficult...