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Trial record 1 of 1 for:    KISIMA 02
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A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)

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ClinicalTrials.gov Identifier: NCT05846516
Recruitment Status : Recruiting
First Posted : May 6, 2023
Last Update Posted : January 23, 2024
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Amal Therapeutics

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: VSV-GP154 Drug: ATP150 Drug: ATP152 Drug: Ezabenlimab Phase 1

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: For Part C: parallel and randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : March 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A Drug: VSV-GP154
Injection

Drug: ATP150
Injection

Drug: ATP152
Injection
Experimental: Cohort B Drug: VSV-GP154
Injection

Drug: ATP150
Injection

Drug: ATP152
Injection

Drug: Ezabenlimab
Infusion
Experimental: Cohort C Treatment Drug: VSV-GP154
Injection

Drug: ATP150
Injection

Drug: ATP152
Injection

Drug: Ezabenlimab
Infusion
No Intervention: Cohort C Observational


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of dose-limiting toxicity (DLT) [ Time Frame: Over at least 35 days ]
    Part A and B

  2. Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier. [ Time Frame: Throughout the study, on average 2.4 years ]
    Part C


Secondary Outcome Measures :
  1. Proportion of patients achieving ctDNA clearance [ Time Frame: Up to 12 months ]
    Part C

  2. Proportion of patients experiencing ctDNA non-progression [ Time Frame: up to 12 months ]
    Part C

  3. Occurrence of dose-limiting toxicity (DLT) [ Time Frame: Throughout the study, up to 7.5 months ]
    Part C


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05846516


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

Locations
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United States, California
USC/Norris Comprehensive Center Recruiting
Los Angeles, California, United States, 90033
Contact: Victoria Soto       soto_v@med.usc.edu   
Principal Investigator: Heinz-Josef Lenz, MD         
University of California Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Lisa-Maria Yonemoto       LYonemoto@mednet.ucla.edu   
Principal Investigator: Zev Aryeh Wainberg, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610-0278
Contact: Britanny Lansford       bpolo6962@ufl.edu   
Principal Investigator: Thomas J. George, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Paige Buzenski       buzenskp@karmanos.org   
Principal Investigator: Anthony Shields, MD,PhD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Pharr       CT.gov@nyulangone.org   
Principal Investigator: Paul Oberstein, MD, MS         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Leena Abraham       labraha@mdanderson.org   
Principal Investigator: Shubham Pant, MD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Carrie Friedman, RN       Carrie.Friedman@usoncology.com   
Principal Investigator: Alexander Spira, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Mannat Sukhija       mannat.sukhija@virginiamason.org   
Principal Investigator: Vincent Joseph Picozzi, MD         
Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Virginie Ancrenaz       virginie.ancrenaz@hcuge.ch   
Principal Investigator: Thibaud Koessler         
Sponsors and Collaborators
Amal Therapeutics
Boehringer Ingelheim
Investigators
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Principal Investigator: Paul Oberstein, MD NYU Langone Health
Principal Investigator: Shubham Pant, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: Amal Therapeutics
ClinicalTrials.gov Identifier: NCT05846516    
Other Study ID Numbers: KISIMA-02
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amal Therapeutics:
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:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms