drugset / Trial / NCT06411691
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer
Phase 1
Recruiting
54 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agenus Inc. · collabNational Cancer Institute (NCI) · collabPrivate Philanthropic Funds · collabUnited States Department of Defense · collab
NaSingle-groupOpen-labelTreatment
Summary
Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line chemotherapy.
Timeline
- Start
- 2025-06-24
- Primary completion
- 2028-03-01
- Completion
- 2029-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balstilimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Botensilimab | Monoclonal antibody | 75 mg | Intravenous |
| Subject | SLP mKRASvax | Vaccine | 0.3 mg | Subcutaneous |
| Background | Hiltonol | Other / unclassified | 0.5 mg | Subcutaneous |