Clinical Trial

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-03-01 -> 2029-11-01 2026-07-28
minor Completion pushed: 2029-07-01 -> 2030-11-01 2026-07-28
Trial Details
NCT Number NCT06411691
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Agenus Inc., Private Philanthropic Funds, National Cancer Institute (NCI), United States Department of Defense
Conditions Colorectal Cancer, Pancreatic Cancer
Enrollment 54 participants
Start Date 2024-11-04
Primary Completion 2029-11-01 (estimated)
Study Completion 2030-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-31