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Also known as CpG Class C Immunostimulatory Sequence (ISS), TLR9 Agonist, TLR9 Agonist SD-101, ISS-ODN SD-101
SD-101 · 2 trials · 4 indications
Adverse events, serious adverse events, and clinical laboratory values outside normal limits will be listed for each patient and summarized by body system and dose level in frequency tables. Severity will be graded by Common Terminology Criteria for Adverse Events version 5.0.
| Arm | Type | Description |
|---|---|---|
| Treatment (SD-101, radiation therapy, nivolumab) | EXPERIMENTAL | Patients receive TLR9 agonist SD-101 intratumorally on days 1 and 8 of cycle 1 and day 1 of cycles 2-5. Treatment repeats every 2 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy on days 1, 3, 5, 8, and 10 of cycle 1. Patients also receive nivolumab IV over 30 minutes on day 2. Cycles with nivolumab repeat every 2 weeks for 24 months in the absence of disease progression or unacceptable toxicity. |
| Active (SD-101) | EXPERIMENTAL | SD-101 in cohorts of escalating doses |
| Name | Type | Description |
|---|---|---|
| Nivolumab | BIOLOGICAL | Given IV |
| Radiation Therapy | RADIATION | Undergo radiation therapy |
| TLR9 Agonist SD-101 | DRUG | Given intratumorally |
| SD-101 | DRUG | Intramuscular (IM) |
| ribavirin | DRUG | oral, 2 times per day, for 2 months |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 - 2 * Able and willing to provide written informed consent * Pathology confirmed pancreatic adenocarcinoma by histology or cytology * Life expectancy \>= 3 months * Progression during or after greater than ...
SD-101 is being developed for the treatment of chronic hepatitis C virus infection. It is an investigational small molecule studied as a novel C type Toll-like receptor 9 agonist. Development has focused on evaluating its safety in adults with chronic HCV infection.
SD-101 is a C type Toll-like receptor 9 (TLR9) agonist. It is designed to activate TLR9, a receptor involved in innate immune recognition, to stimulate immune responses against chronic hepatitis C virus infection. It is characterized as a small molecule and is not a direct-acting antiviral.
SD-101 is being developed by Dynavax Technologies Corporation, which trades on the Nasdaq under the ticker DVAX. The company sponsored the Phase 1 study of SD-101 in chronic hepatitis C infection conducted in Poland.
SD-101 is in Phase 1 development for chronic hepatitis C infection. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational agent and has not been approved by the FDA for any indication.
SD-101 has been studied in one completed Phase 1 trial, NCT00823862, titled a safety study of SD-101, a novel C type Toll-like receptor 9 agonist, for the treatment of chronic hepatitis C virus infection. The trial enrolled 34 adults in Poland and was randomized but uncontrolled.