Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ISS-ODN SD-101, SD-101
TLR9 Agonist 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 ...
TLR9 Agonist SD-101 is an investigational small molecule developed by Dynavax Technologies Corporation (DVAX). It is being studied in oncology, specifically for metastatic pancreatic adenocarcinoma, and works by targeting the TLR9 receptor. It has been evaluated in a Phase 1 clinical trial and is not approved for commercial use.
TLR9 Agonist SD-101 is being studied for the treatment of metastatic pancreatic adenocarcinoma, including chemotherapy-refractory and stage IV pancreatic cancer. The clinical program has focused on patients with advanced pancreatic cancer that has progressed after prior chemotherapy. It is an investigational agent and has not been approved for any indication.
TLR9 Agonist SD-101 targets TLR9, a receptor belonging to the toll-like receptor family. TLR9 is involved in innate immune recognition, and the drug is designed as a small molecule agonist of this receptor. This mechanism is being explored in oncology to stimulate immune responses against pancreatic tumors.
TLR9 Agonist SD-101 is developed by Dynavax Technologies Corporation, which trades on the Nasdaq under the ticker DVAX. Dynavax is the sponsor of the clinical program evaluating this TLR9 agonist in metastatic pancreatic adenocarcinoma.
TLR9 Agonist SD-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program has been completed, with one trial conducted in patients with metastatic pancreatic adenocarcinoma.
TLR9 Agonist SD-101 has been evaluated in one completed Phase 1 trial, NCT04050085, titled SD-101, Nivolumab, and Radiation Therapy in Treating Patients With Chemotherapy-Refractory Metastatic Pancreatic Cancer. The trial enrolled 6 patients in the United States and studied the drug in combination with nivolumab and radiation therapy.