Trial Title:
A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)
NCT ID:
NCT05846516
Condition:
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
For Part C: parallel and randomized
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VSV-GP154
Description:
Injection
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C Treatment
Intervention type:
Drug
Intervention name:
ATP150
Description:
Injection
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C Treatment
Intervention type:
Drug
Intervention name:
ATP152
Description:
Injection
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C Treatment
Intervention type:
Drug
Intervention name:
Ezabenlimab
Description:
Infusion
Arm group label:
Cohort B
Arm group label:
Cohort C Treatment
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)
Criteria for eligibility:
Criteria:
Key inclusion criteria
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
with KRAS G12D or KRAS G12V mutation.
- ECOG performance status of 0 or 1.
- Patients with advanced or metastatic disease who completed at least 16 weeks of
standard systemic chem-/chemoradiotherapy and achieved a partial response or stable
disease.
- Patients who underwent confirmed R0 or R1 resection and completed at least 3 months
of combined peri-adjuvant multiagent chemotherapy.
- No evidence of disease progression or recurrence.
- Start of study treatment within 12 weeks from the last curative treatment (resected
PDAC).
- Life expectancy at least 12 months (resected PDAC), or at least 6 months
(advanced/metastatic PDAC).
- Archival tumor tissue availability for central KRAS analysis.
Key exclusion criteria
- Not yet recovered from surgery (resected PDAC).
- Gastro-intestinal bowel obstruction.
- Other malignancy within the last 3 years.
- Prior chemotherapy or targeted small molecule therapy within 14 (locally
advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study
treatment.
- Prior radiotherapy within 14 (advanced/metastatic PDAC) or 28 (resected PDAC) days
from initiation of study treatment.
- Prior use of immunotherapeutic agents, including but not limited to checkpoint
inhibitors or VSV-based agents.
- Diagnosis of immunodeficiency.
- Chronic systemic treatment with steroids or other immunosuppressive medications.
- Active autoimmune disease requiring systemic treatment within the last 2 years.
- Use of Tamoxifen within 1 month prior to start of study treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC/Norris Comprehensive Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria Soto
Email:
soto_v@med.usc.edu
Investigator:
Last name:
Heinz-Josef Lenz, MD
Email:
Principal Investigator
Facility:
Name:
University of California Los Angeles (UCLA)
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa-Maria Yonemoto
Email:
LYonemoto@mednet.ucla.edu
Investigator:
Last name:
Zev Aryeh Wainberg, MD
Email:
Principal Investigator
Facility:
Name:
University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Russen McKenna
Email:
Mckenna.russen@cuanschutz.edu
Investigator:
Last name:
Sunnie S. Kim, MD
Email:
Principal Investigator
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32610-0278
Country:
United States
Status:
Recruiting
Contact:
Last name:
Britanny Lansford
Email:
bpolo6962@ufl.edu
Investigator:
Last name:
Thomas J. George, MD
Email:
Principal Investigator
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melinda Janice Porter
Phone:
(321)841-7246
Email:
Janice.Porter@orlandohealth.com
Investigator:
Last name:
Omar Kayaleh, MD
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paige Buzenski
Email:
buzenskp@karmanos.org
Investigator:
Last name:
Anthony Shields, MD,PhD
Email:
Principal Investigator
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pharr
Email:
CancerTrials@nyulangone.org
Investigator:
Last name:
Paul Oberstein, MD, MS
Email:
Principal Investigator
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Layla Labbaf
Email:
layla.labbaf@uhhospitals.org
Investigator:
Last name:
Amit Mahipal, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leena Abraham
Email:
labraha@mdanderson.org
Investigator:
Last name:
Shubham Pant, MD
Email:
Principal Investigator
Facility:
Name:
START - South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Gomez
Email:
Elizabeth.Gomez@startsa.com
Investigator:
Last name:
Drew Rasco, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Friedman, RN
Email:
Carrie.Friedman@usoncology.com
Investigator:
Last name:
Alexander Spira, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mannat Sukhija
Email:
mannat.sukhija@virginiamason.org
Investigator:
Last name:
Vincent Joseph Picozzi, MD
Email:
Principal Investigator
Facility:
Name:
University Hospital of Lausanne (CHUV)
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Anna Motterle
Email:
Anna.Motterle@chuv.ch
Investigator:
Last name:
Antonia Digklia, Dr
Email:
Principal Investigator
Facility:
Name:
University Hospital of Bern (Inselspital)
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Lena Albihn-Boland
Email:
lena.albihn-boland@insel.ch
Investigator:
Last name:
Martin Berger, Dr
Email:
Principal Investigator
Facility:
Name:
University Hospitals of Geneva (HUG)
Address:
City:
Geneva
Zip:
1205
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Virginie Ancrenaz
Email:
virginie.ancrenaz@hug.ch
Investigator:
Last name:
Thibaud Koessler
Email:
Principal Investigator
Start date:
March 13, 2023
Completion date:
March 2027
Lead sponsor:
Agency:
Amal Therapeutics
Agency class:
Industry
Collaborator:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Amal Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05846516
