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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05846516
Other study ID # KISIMA-02
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 13, 2023
Est. completion date March 2027

Study information

Verified date May 2024
Source Amal Therapeutics
Contact AMAL Therapeutics
Phone +41 (0) 22 594 39 52
Email RESContact.GVA@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 85
Est. completion date March 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VSV-GP154
Injection
ATP150
Injection
ATP152
Injection
Ezabenlimab
Infusion

Locations

Country Name City State
Switzerland University Hospital of Bern (Inselspital) Bern
Switzerland University Hospitals of Geneva (HUG) Geneva
Switzerland University Hospital of Lausanne (CHUV) Lausanne Default
United States University of Colorado Hospital Aurora Colorado
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Karmanos Cancer Institute Detroit Michigan
United States Virginia Cancer Specialists Fairfax Virginia
United States University of Florida Gainesville Florida
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States University of California Los Angeles (UCLA) Los Angeles California
United States USC/Norris Comprehensive Center Los Angeles California
United States NYU Langone Health New York New York
United States START - South Texas Accelerated Research Therapeutics San Antonio Texas
United States Virginia Mason Medical Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Amal Therapeutics Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of dose-limiting toxicity (DLT) Part A and B Over at least 35 days
Primary Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier. Part C Throughout the study, on average 2.4 years
Secondary Proportion of patients achieving ctDNA clearance Part C Up to 12 months
Secondary Proportion of patients experiencing ctDNA non-progression Part C up to 12 months
Secondary Occurrence of dose-limiting toxicity (DLT) Part C Throughout the study, up to 7.5 months
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