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


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.
Primary Purpose
Study Type
Phase I


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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

Join this Trial

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Study Stats
Protocol No.
Pancreatic Cancer
Lisa Yonemoto
  • UCLA Santa Monica
For Providers
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