RECRUITING

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

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Conditions

Pancreatic Ductal AdenocarcinomaKISIMA-02PDACATP150ATP152EzabenlimabVSV-GP154Adjuvant settingResected pancreatic ductal adenocarcinomaMetastatic pancreatic ductal adenocarcinomaLocally advanced pancreatic ductal adenocarcinomaResected PDACMetastatic PDACLAPC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-03-13
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05846516

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

AMAL Therapeutics
CONTACT
+41 (0) 22 594 39 52
RESContact.GVA@boehringer-ingelheim.com

Principal Investigator

Paul Oberstein, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Shubham Pant, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

USC/Norris Comprehensive Center
Los Angeles, California, 90033
United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
University of Florida
Gainesville, Florida, 32610-0278
United States
Orlando Health
Orlando, Florida, 32806
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
NYU Langone Health
New York, New York, 10016
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
START - South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Amal Therapeutics

  • Paul Oberstein, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Shubham Pant, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-03-13
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • KISIMA-02
  • PDAC
  • ATP150
  • ATP152
  • Ezabenlimab
  • VSV-GP154
  • Adjuvant setting
  • Resected pancreatic ductal adenocarcinoma
  • Metastatic pancreatic ductal adenocarcinoma
  • Locally advanced pancreatic ductal adenocarcinoma
  • Resected PDAC
  • Metastatic PDAC
  • LAPC

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma