Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06411691

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-18

54

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

A

Agenus Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed pancreatic or colon cancer
  • Tumor lesions suitable for repeated biopsy and willingness to undergo biopsies at baseline and during treatment if clinically safe
  • Measurable disease based on RECIST 1.1 criteria
  • Sufficient and accessible tissue available for next generation sequencing and immune-phenotyping
  • Presence of one of the KRAS mutations targeted by the vaccine in the tumor
  • Cohort A: Received 4-6 months of first-line chemotherapy (FOLFIRINOX or gemcitabine+nab-paclitaxel) for metastatic unresectable PDAC
  • Cohort B: Received 4-6 months of first-line standard chemotherapy per NCCN guidelines for metastatic CRC
  • Cohort C: Received no more than 3 lines of systemic chemotherapy including prior KRAS inhibitor
  • Eastern Cooperative Oncology Group (ECOG) performance status 0
  • Life expectancy greater than 3 months
  • Adequate organ and bone marrow function as defined by laboratory tests before study drug
  • Women of childbearing potential must have negative pregnancy test and follow contraceptive guidelines
  • Men must use acceptable birth control during the study
  • Ability to understand and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Candidate for definitive surgical resection
  • Known brain metastases or leptomeningeal spread
  • Prior treatment with immunotherapy agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4
  • Receiving active immunosuppressive agents or chronic systemic corticosteroids within 14 days before vaccine treatment
  • Active autoimmune disease requiring systemic treatment in past 5 years or severe autoimmune disease history
  • Known interstitial lung disease
  • Pulse oximetry less than 95% on room air
  • Requires home oxygen
  • Infection with HIV, hepatitis B, or hepatitis C
  • Uncontrolled illness including serious infection, heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric/social conditions limiting compliance
  • Diagnosis of another cancer or myeloproliferative disorder within past 5 years except certain low-risk cancers
  • Recent surgery within 28 days before dosing except minor procedures
  • Receipt of any non-oncology live vaccine within 28 days before study treatment
  • Regular use of illicit drugs or substance abuse that could interfere with study adherence
  • Any other medical, psychiatric, or social reason deemed unsuitable by the investigator
  • Unwilling or unable to follow study schedule
  • Pregnant or breastfeeding
  • Radiological or clinical pleural effusions or ascites
  • History of malignant small bowel obstruction
  • On parenteral nutrition
  • Known or suspected hypersensitivity to Hiltonol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

C

Colleen Apostol, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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