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SD-101 · 2 trials · 2 indications
The primary endpoint is the number and frequency of adverse events related to cryoablation and hepatic artery infusion of SD-101 in combination with durvalumab and tremelimumab. Adverse events (AEs) during the 6 months following Cryo+SD-101 will be recorded. The NCI CTCAE version 5.0 will be used to grade adverse events. Incidence of AEs will be summarized by event type, grade and body system. Particularly, the rates of infusion reactions, major bleeding, major infection, and grade 3 or above non-infection adverse events will be reported. The proportion of patients having each type of adverse event will be summarized along with a corresponding 90% confidence interval calculated using the exact method. The rate and 90% exact CI of subjects who experience serious adverse events will also be reported.
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 | Participants will be treated with cryoablation and intrahepatic artery infusion of SD-101. This treatment will be followed by administration of the immune checkpoint inhibitors Tremelimumab and Durvalumab (STRIDE regimen). Tremelimumab 300mg will be given intravenously once, 7-10 days after cryoablation + SD-101. Durvalumab 1500mg will be given intravenously at the same time as Tremelimumab, and then every 28 days (on day 1 of every subsequent cycle). |
| Name | Type | Description |
|---|---|---|
| SD-101 | DRUG | Toll-like receptor 9 (TLR9) agonist |
| Cryotherapy | DEVICE | Cryoablation of liver |
| Tremelimumab | DRUG | Anti-CTLA4 |
| Durvalumab | DRUG | Anti-PDL1 |
| anti-PD-1 | BIOLOGICAL | In the Phase 1b, anti-PD-1 will be administered together with SD-101 |
Inclusion Criteria: * Willing and able to provide written informed consent prior to performance of any study- specific procedures. * Age ≥ 18 years. * Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by Am...
SD-101 is an investigational small molecule being studied for locally advanced pancreatic adenocarcinoma and hepatocellular carcinoma. It is delivered through pressure-enabled intrapancreatic or arterial infusion and is combined with checkpoint blockade or other agents in clinical trials.
SD-101 is being developed by TriSalus Life Sciences, Inc., a company traded under the ticker TLSI. The drug is in Phase 1 clinical development for oncology indications.
SD-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently active but not recruiting participants.
SD-101 is being studied in two Phase 1 trials. NCT05607953 evaluates pressure-enabled intrapancreatic delivery of SD-101 with checkpoint blockade for locally advanced pancreatic adenocarcinoma. NCT06710223 studies cryoablation and arterial infusion of SD-101 with durvalumab and tremelimumab for hepatocellular carcinoma.
SD-101 is a distinct investigational small molecule developed by TriSalus Life Sciences. It is not known to be the same as any other approved or marketed drug.