A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT05846516
- Lead Sponsor
- Amal Therapeutics
- Brief Summary
The goal of this clinical trial is to test an experimental treatment (immunotherapy) in pancreatic cancer patients. The main research objectives are:
* to evaluate if the KISIMA-02 treatment is safe and well-tolerated (first part)
* to evaluate if the KISIMA-02 treatment has an impact on the time to observe a possible reappearance of the tumor (second part)
Participants will receive:
i) a therapeutic protein vaccine ATP150 or ATP 152 ii) a viral vector VSV-GP154 iii) an immune checkpoint inhibitor Ezabenlimab In the second part of the study, researchers will compare treatment group versus observational group.
- Detailed Description
This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab.
COMPLETED - Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment
ONGOING - Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment Cohort B1, B2, B3: dose escalation
NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment (treatment versus observational arm)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort A VSV-GP154 - Cohort A ATP150 - Cohort A ATP152 - Cohort B VSV-GP154 - Cohort B ATP150 - Cohort B ATP152 - Cohort B Ezabenlimab - Cohort C Treatment VSV-GP154 - Cohort C Treatment ATP150 - Cohort C Treatment ATP152 - Cohort C Treatment Ezabenlimab -
- Primary Outcome Measures
Name Time Method Occurrence of dose-limiting toxicity (DLT) Over at least 35 days Part A and B
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier. Throughout the study, on average 2.4 years Part C
- Secondary Outcome Measures
Name Time Method Proportion of patients experiencing ctDNA non-progression up to 12 months Part C
Proportion of patients achieving ctDNA clearance Up to 12 months Part C
Occurrence of dose-limiting toxicity (DLT) Throughout the study, up to 7.5 months Part C
Related Research Topics
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Trial Locations
- Locations (15)
USC/Norris Comprehensive Center
🇺🇸Los Angeles, California, United States
University of California Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
START - South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
NYU Langone Health
🇺🇸New York, New York, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University Hospital of Lausanne (CHUV)
🇨ðŸ‡Lausanne, Default, Switzerland
University Hospital of Bern (Inselspital)
🇨ðŸ‡Bern, Switzerland
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University Hospitals of Geneva (HUG)
🇨ðŸ‡Geneva, Switzerland