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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06411691
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KRAS Vaccine with Poly-ICLC adjuvant — DRUG
    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
  • Balstilimab — DRUG
    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
  • Botensilimab — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 24, 2025
Status verified
Dec 2025
Primary completion
Mar 1, 2028
Completion
Jul 1, 2029

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SLP mKRASvax (Up to 1.8mg peptide + 0.5 mg Poly-ICLC (Hiltonol), Botensilimab and Balstilimab

Primary Outcome Measure

Cohort A: Progression-free Survival (PFS) for maintenance mPDAC cohort [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231
Colleen Apostol, RN
[email protected]
410-614-3644

Find similar trials in Baltimore, MD

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

Related Studies