A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)

Description

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Overview

Study Details

Study overview

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.

A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients With KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (KISIMA-02)

A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)

Condition
Pancreatic Ductal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

USC/Norris Comprehensive Center, Los Angeles, California, United States, 90033

Los Angeles

University of California Los Angeles (UCLA), Los Angeles, California, United States, 90095

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

Gainesville

University of Florida, Gainesville, Florida, United States, 32610-0278

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

New York

NYU Langone Health, New York, New York, United States, 10016

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

START - South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Amal Therapeutics,

    Paul Oberstein, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

    Shubham Pant, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

    Study Record Dates

    2027-03