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ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Adenocarcinoma

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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

  • Sex at Birth: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Pancreas

Study Purpose

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.

Principal Investigator
Amit Mahipal MD
Department/Division
Cancer (Digestive System)

Locations

UH Seidman Cancer Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: STUDY20230845
  • StudyID: AMAL1223
  • ClinicalTrials.gov: NCT05846516
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