The Seven Trial: Exploiting the Unfolded Protein Response
Summary
The goal of this investigator initiated interventional study is to improve the response to the anticancer treatments (chemotherapy) in people who have previously untreated metastatic pancreas cancer. The main question it aims to answer is: • Do new types of immune-based therapies, called botensilimab, and balstilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine + cisplatin, and oral medications of chloroquine and celecoxib help patients with previously untreated metastatic pancreatic cancer? Participants will be administered two immune-based therapies: * Botensilimab (also referred to as AGEN1811) * Balstilimab (also referred to as AGEN2034) Patients will be evaluated when given in combination with: * Triple chemotherapy (nab-paclitaxel + gemcitabine + cisplatin), plus two oral medications: * chloroquine * celecoxib
Timeline
- Start
- 2025-01-09
- Primary completion
- 2025-12-22
- Completion
- 2025-12-22
Publications
- Background Malhotra JD, Kaufman RJ. The endoplasmic reticulum and the unfolded protein response. Semin Cell Dev Biol. 2007 Dec;18(6):716-31. doi: 10.1016/j.semcdb.2007.09.003. Epub 2007 Sep 8.
- Background Botrus G, Miller RM, Uson Junior PLS, Kannan G, Han H, Von Hoff DD. Increasing Stress to Induce Apoptosis in Pancreatic Cancer via the Unfolded Protein Response (UPR). Int J Mol Sci. 2022 Dec 29;24(1):577. doi: 10.3390/ijms24010577.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balstilimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Botensilimab | Monoclonal antibody | 50 mg | Intravenous |
| Subject | Celecoxib | Other / unclassified | 200 mg | Oral |
| Subject | Chloroquine | Small molecule | 500 mg | Oral |
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |