Back to resultsA Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VSV-GP154
ATP150
ATP152
Ezabenlimab
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring 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
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
Sites / Locations
- USC/Norris Comprehensive CenterRecruiting
- University of California Los Angeles (UCLA)Recruiting
- University of FloridaRecruiting
- NYU Langone HealthRecruiting
- Virginia Cancer SpecialistsRecruiting
- Virginia Mason Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Cohort A
Cohort B
Cohort C Treatment
Cohort C Observational
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of dose-limiting toxicity (DLT)
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.
Part C
Secondary Outcome Measures
Proportion of patients achieving ctDNA clearance
Part C
Proportion of patients experiencing ctDNA non-progression
Part C
Occurrence of dose-limiting toxicity (DLT)
Part C
Full Information
NCT ID
NCT05846516
First Posted
April 18, 2023
Last Updated
August 15, 2023
Sponsor
Amal Therapeutics
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT05846516
Brief Title
A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amal Therapeutics
Collaborators
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment
Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment
Part C (resected PDAC patients) Cohort C: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment (treatment versus observational arm)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
For Part C: parallel and randomized
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Title
Cohort B
Arm Type
Experimental
Arm Title
Cohort C Treatment
Arm Type
Experimental
Arm Title
Cohort C Observational
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
VSV-GP154
Intervention Description
Injection
Intervention Type
Drug
Intervention Name(s)
ATP150
Intervention Description
Injection
Intervention Type
Drug
Intervention Name(s)
ATP152
Intervention Description
Injection
Intervention Type
Drug
Intervention Name(s)
Ezabenlimab
Intervention Description
Infusion
Primary Outcome Measure Information:
Title
Occurrence of dose-limiting toxicity (DLT)
Description
Part A and B
Time Frame
Over at least 35 days
Title
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
Description
Part C
Time Frame
Throughout the study, on average 2.4 years
Secondary Outcome Measure Information:
Title
Proportion of patients achieving ctDNA clearance
Description
Part C
Time Frame
Up to 12 months
Title
Proportion of patients experiencing ctDNA non-progression
Description
Part C
Time Frame
up to 12 months
Title
Occurrence of dose-limiting toxicity (DLT)
Description
Part C
Time Frame
Throughout the study, up to 7.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMAL Therapeutics
Phone
+41 (0) 22 594 39 52
Email
RESContact.GVA@boehringer-ingelheim.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Oberstein, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shubham Pant, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Soto
Email
soto_v@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Lenz, MD
Facility Name
University of California Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa-Maria Yonemoto
Email
LYonemoto@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Zev Aryeh Wainberg, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0278
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britanny Lansford
Email
bpolo6962@ufl.edu
First Name & Middle Initial & Last Name & Degree
Thomas J. George, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pharr
Email
CT.gov@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Paul Oberstein, MD, MS
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Friedman, RN
Email
Carrie.Friedman@usoncology.com
First Name & Middle Initial & Last Name & Degree
Alexander Spira, MD
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micaela Costello
Email
Micaela.Costello@vmfh.org
First Name & Middle Initial & Last Name & Degree
Vincent Joseph Picozzi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)
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