drugset / Trial / NCT06782932
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
Phase 1/2
Recruiting
38 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agenus Inc. · collabLustgarten Foundation · collabOncovir, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.
Timeline
- Start
- 2025-05-27
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AGEN2373 | Unknown | 1 mg/kg | Intravenous |
| Subject | AGEN2373 | Unknown | 3 mg/kg | Intravenous |
| Subject | AGEN2373 | Unknown | 10 mg/kg | Intravenous |
| Subject | GVAX | Vaccine | 5e+08 cells | Other |
| Subject | mKRASvax | Unknown | 0.3 mg | Subcutaneous |
| Background | Balstilimab | Monoclonal antibody | 450 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Background | Hiltonol | Other / unclassified | 0.5 mg | Subcutaneous |