RecruitingPhase 1NCT06411691

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

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

54 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized cancer vaccine targeting KRAS gene mutations, combined with two immunotherapy drugs (balstilimab and botensilimab), in patients with advanced colorectal cancer or pancreatic cancer whose tumors do not respond to immunotherapy alone (MSS/MMR-proficient tumors). KRAS mutations are very common in these cancers and have historically been difficult to target. **You may be eligible if...** - You are 18 or older with confirmed pancreatic cancer or colorectal cancer - Your tumor has a specific KRAS gene mutation included in the vaccine - Your tumor has measurable disease and is accessible for biopsies - You have completed 4–6 months of standard first-line chemotherapy for your cancer type **You may NOT be eligible if...** - Your tumor does not have one of the targeted KRAS mutations - You are unable or unwilling to undergo tumor biopsies - You have insufficient tissue for genetic testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKRAS 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

DRUGBalstilimab

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

DRUGBotensilimab

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


Locations(1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

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NCT06411691


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