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

PHASE1RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 4, 2024

Primary Completion Date

November 1, 2028

Study Completion Date

November 1, 2028

Conditions
Colorectal CancerPancreatic Cancer
Interventions
DRUG

KRAS Vaccine with Poly-ICLC adjuvant

"SLP mKRASvax with Poly-ICLC adjuvant will be administered on days 1, 8, 15 and 22 in Cycle 1 (Prime Phase) and on day 1 in cycle 4 and every other cycle and beyond (Boost Phase). Up to 5 subcutaneous injections will be administered in the upper thighs, arms and/or back.~Drug: 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC"

DRUG

Balstilimab

"240 mg will be administered as a 30 minute IV. Infusion (-10/+25 minutes) on day 1 and day 15 during Cycle 1 in Prime Phase and on day 1 and day 15 of every cycle in the Boost Phase beginning on Cycle 2 (for a maximum of 2 years from initial vaccination).~Drug: 240 mg IV"

DRUG

Botensilimab

"75 mg will be administered as a 30 minute IV. Infusion (-10/+25 minutes) on Cycle 1 day 1 in Prime Phase and on Cycle 2 day 15 in the Boost Phase.~Drug: 75 mg IV"

Trial Locations (1)

21231

RECRUITING

Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Agenus Inc.

INDUSTRY

collaborator

Private Philanthropic Funds

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

United States Department of Defense

FED

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT06411691 - KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer | Biotech Hunter | Biotech Hunter